Meet Our Team
CONSULTING TEAM
Asquith, Jean - Senior Consultant, Regulatory Affairs
Begala, Mike - Senior Consultant
Craig, James - Senior Consultant
De Pasquale, Fabio - Senior Consultant
Douglas, Gary, PhD - Senior Consultant, IVD Devices
Goldman, Stuart - Senior Consultant
Huddleston, Teresa - Senior Consultant, Quality Assurance & Regulatory Affairs
Kindsvater, Andre - Senior Consultant
Laufer MD PharmD, Jaap - Vice President, Public & Regulatory Affairs
Loh PhD RAC, Evangeline - Director of Regulatory Affairs
McCoy, Kimberly - Senior Consultant, Quality Assurance & Regulatory Affairs
Oakes, Krista - Senior Consultant
Powell, Julie - Vice President, Quality Assurance & Regulatory Affairs
Scalise, Gary - Senior Consultant
Scott, Michael - Senior Consultant
Thornton, Joe - Senior Consultant
van Keulen, Peter - Senior Consultant
Vincins, Richard - Senior Consultant
Vordtriede, Mark - Senior Consultant
Wisdahl, Daryl - Senior Consultant
MANAGEMENT AND SUPPORT TEAM
Boullie, Ann Marie - Client Support Manager
Braster, Patrick - Director, European Operations
Geranios, Joelene - Executive Assistant to CEO & Office Manager
Gordon, Ian - Senior Vice President
Kolber, Neal - Project Manager
Schorre, Chris - Director of Marketing
Skalsky PhD, Michael - Managing Director, Asia Pacific Operations
Sobkowiak, Martin - Director of Finance
Tang, Shelly - Regulatory Affairs Assistant
van der Woude, Michael - Chief Operating Officer
van de Zande, Julie - Chief Financial Officer
van de Zande, Rene - President & CEO
JEAN ASQUITH - Senior Consultant, Regulatory Affairs
Jean is one of several Emergo consultants with expertise in orthopedic implants and related products. Her expertise in this arena was gained during 15 years with industry leader Zimmer, Inc. Jean held many positions of increasing responsibility at Zimmer, most recently as a Regulatory Affairs Specialist. She is well versed in preparing PMA and FDA 510(k) submissions, European CE Technical Files, Canadian MDL submissions, and other regulatory applications for Japan and Taiwan. She puts this diverse international regulatory expertise to work for clients who market their products worldwide.
As a trained Biomedical Engineer, Jean also brings Emergo clients a deep understanding of implant testing procedures and material biocompatibility issues. She is well versed in FDA, ASTM and ISO procedures and specifications, has written numerous test protocols and is very familiar with finite element analysis.
Education: B.S. in Mechanical Engineering, University of Alabama at Huntsville; M.S. in Biomedical Engineering, University of Alabama at Birmingham
MIKE BEGALA - Senior Consultant
Mike has more than 16 years of experience in the medical device arena. Prior to joining Emergo, Mike worked an an independent consultant providing Quality Management System consulting including auditing, training, procedure development, implementation and transition to ISO 13485:2003 registration. His knowledge of these areas was honed during 8 years spent with Atrion Medical Products, a large device manufacturer in the southern United States.
At Atrion, Mike held a variety of quality and regulatory roles, ensuring company-wide compliance with Food and Drug Administration’s Quality System Regulations, including responsibility for Corrective And Preventive Action system, internal and supplier quality audits and employee training. Mike has prepared many 510(k) applications and Technical Files/Design Dossiers. He also had experience with CFR Parts 210 and 211, biocompatibility testing and sterilization methods.
Education: B.S. in Science in Physics, University of Texas at Austin; M.S in Management, University of Alabama at Huntsville.
Professional Certifications:
Certified Quality Auditor (CQA), Certification Number 28799
ANN MARIE BOULLIE - Client Support Manager
Ann Marie is one of Emergo's most indispensable assets. In her role at Emergo, she is responsible for supporting the needs of our consulting team and several hundred Emergo's Authorized Representative clients worldwide. Among other things, Ann Marie coordinates all product registration work for Emergo clients, handles client inquiries and maintains the security and accuracy of client files. Her pleasant demeanor, attention to detail and "can do" attitude was well honed during four years she spent working as a Hotel Manager for a major international chain.
EDUCATION: University of Texas.
PATRICK BRASTER - Director, European Operations
Patrick Braster has extensive experience working for a leading distribution development company in Europe. This, coupled with his background in marketing management and client relations, gives him a well rounded, real-life understanding of what it takes to properly evaluate, manage and monitor distributors in Europe.
Prior to joining Emergo, Patrick served as International Business Development Manager for EuroDev BV based in Hellendoorn, The Netherlands. In his role with Eurodev, Patrick was responsible for setting up and running the European distributor network of several US consumer and industrial goods manufacturers. He also has worked with an extensive network of distributors throughout Europe, providing service, training and marketing support. Patrick also brings a wealth of knowledge about the medical devices arena to the Emergo team.
Education: BA in International Marketing Management, University of Professional Studies (HES), Amsterdam, The Netherlands
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JIM CRAIG - Senior Consultant
Jim is Senior QA and Regulatory Affairs and an internationally Certified Lead Auditor with more than 25 years experience in the devices, in-vitro diagnostics and aerospace industries. Jim has become an expert on the requirements of the FAA, the JAA, ISO 9000 and AS 9100 over the past thirty years while working for such organizations as the Canadian National Defense, Hawker Siddeley Canada, Inc., International Aerospace Management Company and SparAviation Services. His stellar support and consultation services have been conducted in multiple countries and in the private, public, and governmental sectors.
Professional Certifications:
IRCA, International Register of Certificated Auditors
Registered Quality Management Systems Lead Auditor
RAB Registered Quality Management Systems Lead Auditor qualified to ISO 9001:2000 and certified QS-9000 Lead Auditor
Canadian Medical Device Regulations (CMDCAS)
Education: BSc in Physics & Chemistry, University of Calgary, Alberta, Canada; BA in Economics from Queens University, Ontario, Canada
FABIO DE PASQUALE, MSc, MBA - Senior Consultant
Fabio is based in Vancouver, British Columbia and has almost 20 years of experience working for regulated industries in the QA, licensing and medical fields. Fabio has been the main architect for the design and implementation of corporate Quality Management Systems for many Canadian and US engineering firms involved in the medical, nuclear, wastewater treatment, software industries. He has also been responsible for obtaining medical device certifications under the FDA, Health Canada, and the European CE Mark directives for more than 50 different medical devices.
Before joining Emergo, Fabio spent several years with StarFish Medical as their Director of QA and Regulatory Affairs. He has extensive experience in FDA GMP and ISO 13485:2003 compliance, SOP development and ISO 14971 risk management and analysis. In addition, he has been actively involved in clinical consulting regarding protocol design, monitoring, management and analysis, and preparation of applications for US (IDE), Canadian (ITA) and Europe, and is knowledgeable in the areas of EMC compatibility, biocompatibility, laser, ultrasound and lab system requirements.
Fabio is fluent in English, French and Italian and has a working knowledge of Spanish and German.
Education: MBA in Engineering Management, University of Ottawa. M.Sc. in Mechanical Engineering, University of Pisa, Italy.
GARY DOUGLAS, PhD - Senior Consultant
Dr. Douglas brings more than 25 years of in vitro diagnostics experience to Emergo. Gary applies his knowledge of this industry to address the needs of Emergo Group’s IVD and device clients worldwide. His vast expertise managing development projects in both the US and European markets gives Gary an understanding of the technical as well as the regulatory and compliance issues facing manufacturers.
Prior to joining Emergo, Gary was the Vice President for Assay Commercialization for Lab Now, Inc. Here, he was responsible for development of the technology into a commercially viable in vitro diagnostic platform developed under FDA Quality Systems Regulations and manufactured under cGMP. Gary has extensive experience working for several other biotech and IVD companies including OmniSite BioDiagnostics, Calbiochem, Biotech Resources, Cone Biotech and DNW Biologics. His unique understanding of product development and subsequent regulatory compliance issues is of great benefit to Emergo's clients. Although Gary has a strong background in biotech and IVDs, he has prepared FDA 510(k) submissions and Technical Files for a wide variety of medical devices and IVDs alike.
Education: B.A. from University of Arizona; PhD from University of Texas at Austin.
JOELENE GERANIOS - Executive Assistant to CEO & Office Manager
Keeping an organization running smoothly in a high growth environment is never easy. But even though Emergo has grown by more than 30% each year, Joelene makes sure everyone has what they need ensure efficiency and continue providing a high level of service to clients.
In her role as Office Manager, Joelene ensures the smooth day-to-day operation of the Emergo headquarters in Texas but also supports the needs of Emergo's satellite offices in Europe and Asia. Among her many talents, Joelene is the "voice of Emergo," handling incoming calls from Emergo clients in North America. She is also personal Executive Assistant to CEO Rene van de Zande.
Prior to joining Emergo, Joelene spent eight years with the Texas Youth Commission, supervising a staff of three people, faciliating training, maintaining inventory and supporting the needs of Executive staff.
Education: B.A. in Management and Organizational Sciences from New York University; M.B.A. from Stern School of Business, New York University.
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STUART GOLDMAN - Senior Consultant
If anyone understands the demands placed upon medical device companies, it's Stuart. Before joining Emergo Group, Stuart spent 15 years with CarboMedics, Inc., a manufacturer of high-risk cardiovascular implants. As a Staff Quality Assurance Engineer, he was responsible for all facets of the company’s FDA GMP and ISO 13485 compliance, including New Product Development activities and Quality Management Systems implementation. In addition, Stuart has extensive internal and supplier auditing experience, both domestic and international, and managed the company’s Approved Supplier Program to ensure compliance of its suppliers to CarboMedics’ quality policies and procedures.
Stuart has an in-depth knowledge of the FDA QSR regulations, the European Medical Device Directive and ISO 9001/13485 standards, and with his training as a Materials Engineer, a strong understanding of the interactions and risks associated with the use of advanced materials in medical devices.
In addition to helping Emergo's clients with their Quality System device classification and supplier related issues, Stuart focuses primarily on helping them with their regulatory routes to compliance (i.e., Technical Files to support CE Marking and FDA 510(k) and 513(g) submissions to support US clearance).
Stuart holds numerous quality related certifications through the American Society for Quality and RABQSA International.
Education: BS, Materials Engineering from North Carolina State University
Certifications: Certified Quality Manager (CQM), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) and Quality Management System Auditor (QMS-A).
IAN GORDON - Senior Vice President
Ian has held a variety of operational and financial management positions in several industries including both for-profit and non-profit. He has over 20 years of experience in working with small to medium size businesses where he has handled everything from complete restructuring to bailouts.
Prior to joining Emergo Group, Ian was President of his own management consulting firm where he provided quality assurance and operational management services, including financial management, cash flow, and business management improvements in manufacturing and distribution companies. Ian’s 15 years of experience in large multinational companies have included project management, contract administration as well as administrative and service operations management. He has an excellent track record of integrating business practices with governmental regulations.
Education: BA in Business Management from the University of Tampa, Florida
TERESA HUDDLESTON - Senior Consultant, QA/RA
Teresa has more than 15 years of quality assurance, regulatory, manufacturing and clinical operations experience in the medical device and pharmaceutical arenas. During several years as a Quality Assurance and Drug Supply Specialist with Houston-based Encysive Pharmaceuticals, she worked closely with clinical operations and contract manufacturers to provide investigational supplies and services for worldwide clinical studies (Phase I, II, III and micro-dosing studies).
Teresa’s experience with Guidant Corporation as a Senior Regulatory Compliance Auditor also gives her an in depth understanding of the challenges medical device manufacturers face in maintaining compliance with US and international regulations, and dealing with Notified Bodies and regulatory agencies worldwide.
Prior to joining Guidant, Teresa spent several years with California-based Allergan, Inc. She worked closely with Research & Development and global project management teams to coordinate project activities for toxicology and GMP studies conducted by Therapeutics Optical/OTC, Skin Care and Botox divisions.
Certifications: Certified Quality Auditor (CQA), Certified Quality Manager (CQM)
Memberships: American Society for Quality (ASQ), Food, Drug & Cosmetic Division (ASQ), DIA (Drug Information Association)
Education: B.S. Biology, Winston-Salem State University; M.S. Biology, North Carolina Agricultural and Technical State University, USA.
ANDRE KINDSVATER - Senior Consultant
Andre is based in our Vancouver, British Columbia office and serves Emergo clients throughout North America. Prior to joining Emergo, he spent 14 years in various QA roles with British Columbia-based Xillix Technologies Corp. and VSM MedTech, Ltd. In his roles with these companies, Andre developed, maintained and upgraded quality systems in compliance with FDA GMP, ISO 13485:2003 while meeting additonal regulations required by Canada's Medical Device Regulations (CMDR). He has extensive experience developing CAPA procedures, conducting audits, compiling 510(k) submissions and maintaining QS compliance.
Andre is particularly experienced with software, having spent more than 10 years of his long career as a Systems & Software Engineer. Thus, he provides a wealth of expertise for Emergo clients who market medical devices with a software component. He has put this experience to work in preparing many successful FDA 510(k) and Canadian Medical device Licence submissions plus numerous European Technical Files. Andre is fluent in German and English.
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NEAL KOLBER - Project Manager
Emergo Group has made a significant investment in project management technology and Neal is the person who puts that technology to maximum use for the benefit of our clients. Neal is responsible for assigning, coordinating and scheduling projects for Emergo's worldwide consulting team. His experience in project management was honed during several years spent working for the French Ministry of Education in Lyon, France and his roles in Business Development and Account Management with a Texas-based network security firm and defense contractor. Neal is fluent in French and like any good Project Manager, he is extremely organized, technologically savvy and - due to his years working in France - exceptionally diplomatic. Clients and employees alike enjoy working with Neal.
Education: BA in Arts with International Business Minor. University of Texas at Arlington.
DR. JAAP LAUFER, MD, PharmD - VP, Public & Regulatory Affairs
Dr. Jaap L. Laufer MD PharmD has over 20 years of experience in Regulatory and Medical Affairs at major pharmaceutical and technology-intensive medical device companies. He serves as Senior Regulatory Counsel to the Management or Board of several major medical device manufacturers, but also of venture capital funded companies.
In addition to working with Emergo Group, Dr. Laufer manages his own regulatory consulting firm serving medical device and IVD clients worldwide. He was also VP of Regulatory and Clinical Affairs for LipoMatrix, Inc. in Neuchatel, Switzerland. When Collagen Corp. of Palo Alto, CA, acquired LipoMatrix, he became their Vice President of Regulatory Affairs. Before he joined LipoMatrix, Dr. Laufer held a number of managerial positions of increasing responsibility within Pfizer. In this capacity he was responsible for regulatory approval and compliance, and medical matters concerning a wide variety of active and non-active medical devices.
On top of being an experienced auditor for compliance with ISO (accredited with ZLG) and FDA Quality System Regulations, Dr. Laufer managed many clinical studies, sometimes from inception to publication. He is a regular contributor and past Chairman of Regulatory Affairs Professional Society (RAPS), Europe (1993-1996) and a visiting teacher to the School of Pharmacy at the University of Southern California (USC).
Education: PhD in Pharmacy, University of Groningen, The Netherlands
PhD in Medicine, University of Nijmegen, The Netherlands.
EVANGELINE LOH, PhD, RAC - Director, Regulatory Affairs
Dr. Loh oversees regulatory consulting support for Emergo clients worldwide. Prior to joining Emergo Group, Dr. Loh managed regulatory affairs for the surgery and critical care units of Cook, Inc., one of the largest manufacturers of needles, stents, catheters and wire guides. She has extensive knowledge of US and EU regulations and in addition to working on regulatory submissions for the US and EU, she has worked on regulatory submissions in Canada, Korea, Taiwan, China and Hong Kong.
Prior to her tenure at Cook, Dr. Loh worked for the Division of Biomedical Sciences at the Association of American Medical Colleges (AAMC) in Washington, DC. Her role there was to develop data metrics and quality control measures, and to conduct statistical analysis to evaluate the performance of clinical sites. She also managed a large professional development program comprised of Deans and Faculty involved in biomedical science research.
As a graduate student at the University of Texas Health Science Center at San Antonio for several years, Dr. Loh designed and implemented research protocols to conduct experimental research using complex molecular techniques.
Certifications: Regulatory Affairs Professional Society RAC (US, EU) designation
Education: BS in Microbiology, Cornell University; PhD in Pharmacology, University of Texas Health Science Center at San Antonio.
KIMBERLY McCOY - Senior Consultant, Quality Assurance & Regulatory Affairs
As a Senior Consultant for QA and RA, Kimberly has diverse responsibilites. She is actively involved in helping Emergo clients with varied issues including device assessment, classification, labeling reviewing, and analysis of regulatory documentation.
In her years of experience with notable device manufacturers such as Ethicon Endo-Surgery, Johnson & Johnson, Genzyme Biosurgery and Encore Medical, she frequently performed regulatory analyses for devices, compiled Technical Files and Design Dossiers and prepared FDA (510(k), IDE and PMA submissions. Her knowledge of regulatory issues is supplemented by her experience with quality assurance issues related to ISO 13485:2003 and FDA GMP. She puts this extensive knowledge to work for the benefit of Emergo clients worldwide.
Certifications: Regulatory Affairs Professional Society, RAC (US, EU) designation
Education: B.A. in International Relations, Texas Christian University; Pursuing MBA in Health Care Management, University of Phoenix.
KRISTA OAKES - Senior Consultant
Since 1989 Krista Oakes has been involved in quality assurance and regulatory affairs in the medical device industry. Krista has worked with large and small manufacturers representing a broad spectrum of medical device technologies. Prior positions include Director of Quality Assurance and Regulatory Affairs for Quest Medical, Vice President of Regulatory Affairs and Quality Assurance for Epic Medical, President of Epic Medical, and Vice President - Medical Device Division for Shotwell & Carr.
Krista is an active participant in the medical device industry with memberships in the Regulatory Affairs Professionals Society (RAPS), the American Society for Quality (ASQ), and the Association for the Advancement of Medical Instrumentation (AAMI); and currently serves as the industry co-chair for the Dallas District FDA/Medical Device Industry Coalition. Krista has been an industry speaker and author of articles on practical and efficient approaches to quality systems.
JULIE POWELL - Vice President, Quality Assurance & Regulatory Affairs
Julie is Emergo's VP of QA/RA and a Certified Lead Auditor. She is responsible for assisting clients with the implementation and development of quality and regulatory systems for the medical device industry. Julie also is responsible for the review, compilation and submission of Technical Files and 510(k) applications.
With nearly 30 years of quality/regulatory experience in medical devices and in-vitro diagnostics, she is extremely adept at developing Quality Management Systems in accordance with FDA’s Quality System Requirements (QSR – cGMP, GLP and GCP), ISO 13485, ISO 9001, EN 46001, 93/42/EEC.
She serves currently as a Board Member of the Michigan Medical Device Manufacturers and holds numerous professional certifications.
Education: Parsons Business School, Michigan
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GARY SCALISE - Senior Consultant
Gary Scalise is a Senior Consultant, Quality Assurance and Regulatory Affairs and International Lead Auditor. Gary is responsible for assisting medical device, IVD and pharmaceutical clients with the development, implementation, and auditing of quality and regulatory systems for the device industry in accordance with QSR—cGMP, GLP, and GCP; ISO 13485:2003, MDD 93/42/EEC; IVDD 98/79/EEC, and CMDRs. He has been a corporate staff instructor with the Eaton Quality Institute, and continues to develop and deliver courses in Quality Systems, Process Improvement, Quality Engineering, DOE, SPC, QOS and Auditing.
Gary is highly experienced and registered to audit medical device and pharmaceutical companies. He has been a practicing ASQ certified quality engineer since 1979 and a CQE instructor over 18 years.
Professional Certifications:
RAB and IRCA, International Register of Certificated Auditors
Registered Quality Management Systems Lead Auditor
ANSI-RAB Registered Quality Management Systems Lead Auditor qualified to ISO 9001:2000 Technical Lead Assessor, American Association for Laboratory Accreditation.
CE Marking for Medical Devices and IVD
Education: BS in Broadcast Communications, Temple University, Pennsylvania. MA in Industrial Technology, Western Carolina University, North Carolina.
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CHRIS SCHORRE - Director of Marketing
Chris is Emergo’s Director of Marketing. His responsibilities include the planning, management and measurement of the strategic marketing plans conducted by the Emergo Group team. He is also involved in setting up strategic partnerships with other firms in the USA, Europe and Asia. Chris ensures that the sales team receives the necessary marketing support, and ensures proper communication both within the firm and externally.
Prior to joining Emergo Group, Chris managed direct marketing communications for a division of Zurich Insurance. With a background in marketing and international business, Chris brings to Emergo Group an acquired understanding of worldwide business practices.
Education: BA in Advertising, Michigan State University, East Lansing, Michigan USA
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MICHAEL SCOTT - Senior Consultant
Michael has more than 15 years of experience in medical device, pharmaceutical and IVD device development and manufacturing. Prior to joining Emergo, he was the Manager of Quality for LabNow, Inc, an Austin based biotech startup that developed and manufactured diagnostic tests. While there, he developed and implemented an ISO 13485:2003 and FDA GMP compliant quality system for the firm, including related training programs, SOPs, document control procedures, CAPA programs, and subcontractor evaluation/monitoring standards.
Michael's experience at Lab Now was enhanced by his previous work as a Quality Engineer for Hospira Inc. where he provided technical support and service to control and improve product quality. Michael also spent 11 years in QA with Abbott Laboratories. In his many roles at Abbott, he gained significant experience in the areas of product validation/testing, managing a QA team of 40 people to ensure ongoing compliance with FDA and international regulations. Michael is highly motivated, and adept at recognizing areas for improvement and implementing solutions for increased accuracy and performance.
Education: BA in Biology, University of Texas at Austin; MS in Quality Systems Management, The National Graduate School of Business, Falmouth, Massachusetts, USA
MICHAEL SKALSKY PhD - Managing Director, Asia Pacific Operations
Mike Skalsky serves as Managing Director of Emergo Asia-Pacific Ltd., Emergo Group’s office in Sydney, Australia.
Mike represents Emergo Group in the Asia-Pacific region, and is responsible for increasing awareness of Emergo’s unique set of services among medical device companies doing business in Australia as well as Australian companies expanding abroad.
Mike brings many years of experience in the medical devices industry in Australia, helping companies to develop their products within quality systems as well as formulating market entry and business development programs.
MARTIN SOBKOWIAK - Director of Finance
Martin manages all aspects of accounting and finance for the Emergo Group of companies worldwide including Emergo Group Inc. (US/Canada), Emergo Europe B.V. (Europe), Emergo Japan K.K., Emergo Asia Pacific Pty. Ltd. (Australia) and Jyton & Emergo Medical Technology Co. Ltd. (China). Prior to joining Emergo, Martin was a Senior Accountant for Dell Financial Services in Austin, Texas.
Before joining Dell, he was Controller for Wincor Nixdorf, the world's third largest manufacturer of POS equipment and ATMs with more than 5,000 employees worldwide. His experience with large multinational firms gives him an understanding of complexities of running Emergo's international offices operating on four continents.
Martin is fluent in German and English.
Education: B.A. and M.B.A. in Accounting, Finance and Banking, University of Paderborn, Germany
SHELLY TANG - Regulatory Affairs Assistant
Shelly supports the needs of Emergo's worldwide client base, coordinating regulatory submission documents, assisting with client questions and supporting the Emergo regulatory consulting team.
Her resourceful nature and attention to detail make her a key asset on the Emergo team. Prior to joining Emergo, Shelly held positions that helped refine her customer service and analytical skills. Shelly has a working knowledge of Spanish and Chinese.
Education: Bachelor of Arts in Psychology, Southwestern University
JOE THORNTON - Senior Consultant
Joe brings to the Emergo team high-level reliability engineering and risk assessment expertise of medical devices that has withstood the scrutiny of the FDA, Health Canada and various European Notified Body and Competent Authority technical reviews. With over twenty years of experience in the medical device and aerospace industries, Joe has performed Reliability Engineering and risk assessments on Class I, II, and III medical devices and a multitude of aerospace structures and components.
As a Staff Reliability Engineer at CarboMedics Inc. in Texas, Joe was instrumental in the Company’s risk assessment development, maintenance and design verification activities for its portfolio of medical device products including mechanical and tissue heart valves, annuloplasty and cardiovascular repair products, and instrumentation. Prior to his tenure with CarboMedics, Joe was employed in various staff and senior level reliability engineering positions at Grumman Corporation, Boeing Aerospace, the US Army Strategic Defense Systems Command and CAE-Link Corporation.
Education: US Army School of Engineering and Logistics (SEL) Reliability & Maintainability Engineering Program (Graduated First in Class). B.S. in Mechanical Engineering, University of Florida.
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MICHAEL VAN DER WOUDE - Chief Operating Officer
Michael van der Woude is an international business development expert and has many years of experience in international markets and advising businesses in establishing or expanding their business in the USA and Europe.
Prior to joining Emergo Group as Chief Operating Officer, Michael spent six years as a director for the Netherlands Foreign Investment Agency (NFIA), offering support and expertise to US companies expanding into the European market. Ten years of first hand experience running his own company, and working for a leading multinational financial services company, gave Michael a well rounded understanding of the myriad challeges faced by small and large businesses alike.
As head of Operations for Emergo Group and its subsidiaries, Michael oversees all aspects of day to day activities and focuses his efforts on ensuring that Emergo clients are receiving top quality service.
Education - Masters Degree in Business from the University of Groningen in the Netherlands.
Language proficiency - English and Dutch
JULIE VAN DE ZANDE - Chief Financial Officer
Julie has been working in the international business environment for fifteen years. Her responsibilities include accounting and office management. Her professional experience includes business development, consulting, executive recruitment, government affairs, international trade, legal, public relations, international trade associations, and travel and tourism. Julie is fluent in French, Italian and Spanish.
Education: BA in History, Georgetown University, Washington D.C.; MA in International Relations from the Johns Hopkins University School of Advanced International Studies (SAIS)
RENE VAN DE ZANDE - President & CEO
René is responsible for the overall operations of the Emergo Group including Emergo Europe, Emergo Asia Pacific and Jyton & Emergo Medical Technology, Inc.
Before starting Emergo Group in 1997, he served the international commercial community as Senior Issues Coordinator for the EU Committee of the American Chamber of Commerce in Brussels, Managing Director of the European-American Industrial Council and as Senior Commercial Specialist at the U.S. Mission to the European Union in Belgium.
Having become an expert in the field of Trade and Regulatory Issues, René made the leap into the private sector, establishing Emergo Group to specialize in regulatory issues confronting manufacturers and distributors of medical devices and in-vitro diagnostics.
René has published numerous articles on medical device regulations-related issues. In addition, he is co-author of a series of publications on European product legislation for the US Department of Commerce and National Institute for Standards and Technology (NIST).
Education: Masters degree from the University of Nijmegen, The Netherlands and from The Johns Hopkins University School for Advanced International Studies (SAIS).
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VAN KEULEN, PETER - Senior Consultant
Peter is based in our office in The Netherlands. With more than 20 years of quality assurance and medical device experience, he is no stranger to the device industry. Few people have the breadth of experience that Peter offers to Emergo clients. His initial exposure to the device industry came from seven years as a Research Scientist within the Departments of Cardiology, Pediatrics, and Thoracic Surgery at the Academic Hospital St. Radboud in Nijmegen, Netherlands. While there, Peter designed new methods and equipment to quantify, diagnose and verify blood flow in the heart; evaluated quantitative methods in the field of image analysis, 3D tissue reconstruction and (cardiac) tissue characterization (including X-ray, radioisotope imaging) and much more.
Peter’s first hand experience at the Hospital was especially salient when he joined Notified Body KEMA Medical in Europe as a Project Manager. Here, he assessed Technical Files and Design Dossiers to verify and ensure CE compliance, reviewed safety test protocols/reports, performed on-site quality system audits and worked extensively on software validation.
Most recently, Peter was a Senior Quality and Regulatory Engineer for W.A. Cardio Control BV in the Netherlands, a division of Welch Allyn Inc. Here, he worked in R&D developing cardiopulmonary diagnostic products and patient management systems. He was also responsible for all QA and RA issues for the division and knows first hand the unique challenges facing high risk device manufacturers.
Peter is fluent in German, Dutch and English with a working knowledge of French.
Education: Masters in Applied Physics, University Twente, Enschede, The Netherlands.
RICHARD VINCINS, CQM, CQA - Senior Consultant
Richard brings a wealth of FDA and European regulatory expertise to Emergo, experience gained from 17 years working in quality assurance and regulatory affairs with a variety of medical device companies including Medtronic, Bard and HemaCare. Richard is well-versed in the requirements and implementation of FDA GMP and ISO 13485:2003 and knowledgeable about requirements of the Medical Device Directive (MDD), In Vitro Diagnostics Directive (IVDD), and other directives for CE Marking in the European community.
In addition to his vast knowledge of quality systems regulations, Richard also has experience with clinical trial management, site qualification, monitoring, and regulatory file completion. He has completed numerous CE Technical Files for IVD devices and is a certified Lead Auditor. Risk management is also an area of expertise.
Education: B.S. in Biomedical Biology, Bridgewater State College, Massaschusetts
MARK VORDTRIEDE - Senior Consultant
Mark Vordtriede brings nearly 30 years of experience in manufacturing, design and quality management to the Emergo Group team. After spending several years as a manufacturing engineer, Mark moved into quality management with Westinghouse working to increase production capacity and lower costs through quality system enhancements. Over the course of five years, Mark was able to improve productivity and save his division nearly $5,000,000 in costs. After 12 years with Westinghouse, he became VP of Corporate Quality for Public Safety Equipment Company. During his time there, Mark cut product development lead times from 2.5 years to 6 months and shaved another $2,500,000 in costs with quality process enhancements. With a well rounded background in manufacturing, Mark started his own consulting firm focused on ISO quality system implementations and improvement. Mark is well versed in ISO 9001, ISO 13485, FDA GMP, TS 16949, AS 9100 and ISO 14000.
Education: BS in Civil/Architectural Engineering, Washington University School of Engineering.
DARYL WISDAHL - Senior Consultant
Daryl Wisdahl has more than 14 years of regulatory affairs, clinical research, quality assurance and marketing experience in the medical technology industry. Daryl oversees Emergo operations in western Canada and the northwest USA from his base in Vancouver, British Columbia. He currently works with a number of start-up companies in the region and has previously held positions in his fields of expertise with a number of Vancouver-based medical device companies, such as VSM MedTech Ltd., Response Biomedical Corp. and Xillix Technologies Corp. He holds a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS).
Education: Bachelors of Business Administration from Simon Fraser University in British Columbia, Canada.
