The Emergo Team in North and South America

Emergo Group maintains its offices throughout North and South America, the Asia Pacific region, Europe and the Middle East . Shown below is a selected list of consultants and employees based in our offices in North and South America. Click on one of the following links to meet our team located in: BRAZIL | CANADA | MEXICO | USA

BRAZIL

BRISOLLA, Marcelo - Director, Emergo South America (Brasilia)

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CANADA

CHRISTIE, David - Distribution Consultant (Vancouver)

CRAIG, Jim - Senior Consultant, Quality Assurance (Toronto)

Jim is a Certified Lead Auditor with a long history in the highly regulated, quality-control-conscious aerospace and defense industries. Since 2000, Jim has applied his extensive experience in QMS development and auditing to the medical device industry. He specializes in helping companies develop effective quality management systems that are in full compliance with US, European and Canadian requirements. Documentation development, traceability, internal auditing, Corrective and Preventive Action (CAPA), SOP development and other QA issues are all areas in which Jim has very specific expertise. Because Jim has worked with so many medical device companies making a wide variety of products, he knows how to tailor quality management solutions to fit the specific needs of the clients he represents, and simplify the quality requirements while maintaining regulatory compliance. Education: B.S. in Physics and Chemistry, University of Calgary; Partial B.A. in Economics, Queens University.

DEPASQUALE, Fabio - Senior Consultant, Quality Assurance & Regulatory Affairs (Vancouver)

Fabio has almost 20 years of experience working for regulated industries in the QA, licensing and medical fields. He has been the main architect for the design and implementation of corporate Quality Management Systems for many Canadian and US medical device firms, and has obtained medical device certifications under the US FDA, Health Canada, and the European Directives for more than 50 medical devices. Fabio 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 the preparation of applications for US (IDE), Canada (ITA) and Europe, and is knowledgeable in the areas of EMC compatibility, biocompatibility, laser, ultrasound and lab system requirements. Education: MBA in Engineering Management, University of Ottawa; M.S. in Mechanical Engineering University of Pisa.

KINDSVATER, Andre - Senior Consultant, Software Validation (Vancouver)

Andre is based in our Vancouver, British Columbia office and serves Emergo clients throughout North America. He has developed, maintained and upgraded quality systems in compliance with the US FDA Quality System Regulation, ISO 13485:2003 and the additional requirements of Canada's Medical Device Regulations (CMDR). He has extensive experience developing CAPA procedures, conducting audits, compiling 510(k) submissions and maintaining the compliance of quality management systems with international Standards and regulations. Andre is particularly experienced with software, having spent more than 10 years as a Systems & Software Engineer. Thus, he provides a wealth of expertise for Emergo clients who manufacture imaging equipment or any other medical devices with a software component. Education: M.S. in Electrical Engineering, University of British Columbia, Vancouver; B.S. in Electronics/Systems, Concordia University, Montreal.

WISDAHL, Daryl - Managing Director, Emergo Canada (Vancouver)

Daryl Wisdahl has more than 15 years of regulatory affairs, clinical research, quality assurance, and marketing experience in the medical technology industry. He oversees Emergo's operations in western Canada and the northwest USA from his base in Vancouver, British Columbia. In his position with Emergo, Daryl helps medical device manufacturers from Canada and around the world with issues related to Health Canada Medical Device License (MDL) applications, Technical File construction, clinical evaluations and ISO 13485:2003 implementation in accordance with the Canadian Medical Device Regulations (CMDR). Daryl also conducts training on ISO 13485, auditing and the CMDR, and assists clients with business development in Canada. Education: B.B.A., Simon Fraser University, Burnaby, BC.

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MEXICO

CAPUANO, Daniel - Director, Emergo Mexico (Mexico City)

Based in Mexico City, Daniel is Director of Emergo's operations in Mexico and has nearly 20 years of experience in the medical device industry.  He has worked for major medical device distribution and technical service companies in Mexico and is an expert on cardiovascular devices, especially stents. He is the co-author of two issued patents and one pending application of cardiovascular interventional devices. With firsthand experience running a major medical distribution and consulting company in Mexico, Mr. Capuano knows how manufacturers can successfully navigate the Mexican market, from regulatory approval to distribution management and servicing. Education: B.S. in Biomedical Engineering, Universidad Iberoamericana; MBA, IPADE Business School.

TORRES TELLO, Miguel - Regulatory Affairs Specialist (Mexico City)

Miguel is responsible for supervising technical information and proper documentation management of registration submissions in Mexico. He maintains close contact with medical device manufacturers during different stages of the registration process, from the classification of their products to the final submission of their registration with COFEPRIS, a division of the Mexican Health Ministry. Emergo Mexico benefits from Miguel's broad understanding of biomedical instrumentation from a scientific, technical and commercial perspective, gained from his previous work experience. Prior to joining Emergo, Miguel was a Service and R&D Engineer, during which he participated in the design and development of a ventricular assist device for in vivo trials at the Texas Heart Institute. Miguel also worked on projects related to biomedical instrumentation at the National Institute of Respiratory Diseases in Mexico City and in an artificial vision project at the National Institute of Astrophysics, Optics and Electronics. Education: B.S. in Electrical Engineering, Universidad de las Americas Puebla (UDLAP), Mexico; M.S. (Honors) in Biomedical Engineering, Universidad Autonoma Metropolitana (UAM), Mexico.

VONDERWALDE, Carlos - Director, Emergo Mexico (Mexico City)

Carlos was previously a professor from 1989-1998 at the Universidad Iberoamericana of Mexico City, where he also obtained his B.Sc. in Biomedical Engineering. Since then, Carlos has been involved in the private sector, working as a product specialist in areas of cardiology and urology. In 1996, Carlos worked on the development of the heterologus pericardium covered stent, of which he is credited as the inventor, as stated under several US and world patents and secured the technology for its manufacturing. He has also successfully lead several products toward CE Mark and FDA clearance and has assisted several companies with obtaining ISO 13485. Currently, Carlos is member of SOLACI and the Mexican Society of Cardiology. He participates in conferences and has published several articles in interventional cardiology. Carlos also consults for different medical device companies in his areas of expertise and continues development work for new medical devices for which he has applied for patents in several countries. Education: B.S. in Biomedical Engineering, University Iberoamericana of Mexico City.

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UNITED STATES

ASQUITH, Jean - Senior Consultant, US Regulatory Affairs (Texas)

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. She is well experienced in preparing PMA and FDA 510(k) submissions, European CE Technical Files, Canadian MDL submissions and other regulatory submissions for countries including Japan and Taiwan. As a trained Biomedical Engineer, Jean 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: M.S. in Biomedical Engineering, University of Alabama at Birmingham; B.S. in Mechanical Engineering, University of Alabama at Huntsville.

BEGALA, Mike - Senior Consultant, Quality Assurance & Regulatory Affairs (Texas)

Mike has more than 14 years of experience in the medical device arena. In his role with Emergo, Mike assists medical device clients with a variety of quality assurance issues including ISO 13485 and FDA Quality System Regulation (QSR) compliance, auditing and training. He is well-versed in the quality system regulations of the United States, Canada and Europe and how those regulations overlap and differ from one another. In addition to his experience in the QA arena, Mike also has extensive experience with regulatory affairs issues, including the preparation of European Technical Files and US FDA 510(k) applications. His extensive knowledge of biocompatibility testing, sterilization methods and packaging compliance is also very useful for clients with products for which this is an important regulatory compliance issue. Education: M.S. in Management, University of Alabama; B.S. in Physics, University of Texas at Austin.

BOULLIE, Ann Marie - Executive Assistant to the CEO & International Liaison Manager (Texas)

Ann Marie is the Executive Assistant to the CEO of Emergo Group and acts as International Liaison Manager for all Emergo operations worldwide, including Emergo Group, Emergo Europe, Emergo France, Emergo Mexico, Emergo Japan, Emergo Australia and Jyton & Emergo Medical Technology (China). As the Executive Assistant, she supports the CEO in his duties and promotes the corporate image by representing the CEO internally and externally. Ann Marie assists the CEO in the international expansion of Emergo Group's operations and service offerings, and as International Liaison Manager, she acts as the liaison between North American based clients and Emergo offices overseas during the execution of consulting projects. Education: B.A. in Communications, University of Texas at Austin.

CHAPMAN, Alison - Client Support Manager (Texas)

As Client Support Manager, Alison's responsibilities include assisting with coordinating and assigning projects and providing support to clients for consulting services. Prior to joining Emergo Group, Alison worked with a productivity training company, where she oversaw all of the trainings from beginning to end and offered support to clients, building relationships and providing quality customer service. Emergo Group benefits from Alison's experience in client services and support, sales and marketing and project management, as well as her educational background in global business.  While earning her MBA degree, Alison was involved with several global consulting projects in Costa Rica, Germany and the Czech Republic. Education: B.S. in Human Resource Development, Minor in Business Administration, Texas A&M University; Masters of Business Administration, Concentration in Global Business, St. Edward's University.

CRAWFORD, Heather - Senior Consultant, Quality & Regulatory Compliance (Texas)

Heather has spent her entire career in the medical device industry, and more specifically, in regulatory and quality compliance. During her time with respected manufacturers such as Abbott Laboratories and Sorin Group, she has been responsible for everything from documentation and CAPAs to quality system compliance and PMAs. Armed with this experience, she has an in-depth understanding of the compliance challenges for companies making high risk devices. Education: M.S. in Information Studies, Florida State University; B.S. in Biological Science, Florida State University.

CROWLEY, Tim - Distribution Consultant (Maine)

Tim is a seasoned marketing/sales executive with almost 30 years experience developing new distribution for medical and biotech companies in the US and the EU. He has extensive contacts in all medical specialties and markets, allowing for rapid introduction of new products in any market where a company may be having problems establishing sales. Having established international distribution for numerous companies with full P&L responsibility for all aspects of international operations, Tim is able to quickly assess the best approach for distribution of new products as well as regulatory requirements for medical device companies quickly and efficiently. Education: MBA in Management and Marketing, Columbia Business School; B.A. in History and French Literature, University of Pennsylvania.

DOUGLAS Ph.D., Gary  - Senior IVD Consultant (Texas)

Dr. Douglas brings more than 25 years of In Vitro Diagnostics (IVD) experience to Emergo and applies his knowledge of this industry to address the needs of Emergo's IVD and medical device clients worldwide. His vast expertise managing development projects in both the US and European markets gives Gary an understanding of the technical and regulatory compliance issues facing manufacturers. Gary is actively involved in preparing Technical Files, US FDA 510(k) applications and Investigational Device Exemption (IDE) submissions. His knowledge of the OSHA and CLIA regulations in clinical environments and corresponding US, European and other international quality assurance and regulatory requirements also makes him an invaluable asset to IVD clients. Education: Ph.D, University of Texas at Austin; B.A., University of Arizona.

FARRAR, Sage - Regulatory Research Associate (Alabama)

As Regulatory Research Associate at Emergo Group, Sage's primary responsibilities include researching medical device and IVD regulatory changes worldwide and creating technical content for Emergo Group's websites. Sage is also actively involved in researching and writing articles for international medical device journals and magazines. Sage comes from a background of public health and is fluent in Spanish and comprehensive of Portuguese. Education: B.A. in Spanish with a Pre-Medicine track, Minors in Bioethics and Latin American Studies, Johns Hopkins University; completed coursework at the Johns Hopkins Bloomberg School for Public Health.

FISHER, Cheryl - Senior Consultant, Quality Assurance (California)

In her role with Emergo, Cheryl is responsible for implementing and auditing FDA QSR and ISO 13485 compliant quality systems for medical device and IVD companies. She has extensive experience designing robust quality management systems that withstand regulatory inspections and regularly performs employee training on CE Marking, ISO 13485, FDA GMP and internal auditing. Prior to joining Emergo, Cheryl spent several years with Boston Scientific/Guidant. In this capacity, she performed many ISO 13485 and FDA GMP audits, collaborated with auditees to develop corrective actions, communicated audit results to senior management and trained personnel on device regulations. Cheryl has also worked as a contract auditor for TUV Rheinland, giving her a unique perspective on how device companies should maintain compliance with regulations and standards. Education: B.A. in Liberal Studies, San Jose State University; Graduate work toward MBA, Pepperdine University.

GOLDMAN, Stuart - Senior Consultant, Auditing & Regulatory Affairs (Texas)

If anyone understands the demands placed upon medical device companies, it's Stuart. Before joining Emergo, Stuart spent 15 years with a manufacturer of high-risk cardiovascular implants and was responsible for all facets of the company's compliance with FDA GMP and ISO 13485. He has extensive experience with auditing and quality control of subcontractors. Stuart has an in-depth knowledge of the US FDA regulations, the European Medical Device Directive and ISO 13485 standards. His training as a Materials Engineer gives him a strong understanding of the risks associated with the use of advanced materials in devices. At Emergo, Stuart focuses primarily on helping clients with regulatory compliance including device classification, CE Marking Technical Files, FDA 510(k) submissions and risk analysis. Education: B.S. in Materials Engineering, North Carolina State University.

GUSMAN, Kristi - Administrative Assistant (Texas)

If you call the Texas office of Emergo, Kristi is likely the first voice you will hear. In her role at Emergo, Kristi is responsible for fielding client inquiries, supporting the US consulting team and ensuring that the office runs smoothly. For several years Kristi worked as a Casting Assistant on numerous TV commercials and movies, and it was this experience that taught her the importance of coordination, attention to detail and teamwork. We're pleased to have her as part of the team. Education: B.A. in Radio, Television and Film, University of Texas at Austin.

HATLEY, Mirjam - Green Dot Coordinator (Texas)

Europe has more than two dozen different Green Dot packaging waste compliance programs, each with myriad rules companies must follow to be in compliance with the EU Packaging Waste Directive. It takes excellent organizational skills to manage these complex requirements and keep Emergo clients in compliance. Mirjam does so very effectively. Among other things, she monitors changes to the requirements, prepares/files quarterly packaging reports to EU authorities and interfaces with clients. Her strong background in bookkeeping, office management and media relations, combined with her innate understanding of European business culture (Mirjam is a Swiss native) gives her the ability to communicate effectively with EU regulatory authorities. Being fluent in German and conversant in French also helps! Education: Degree in Real Estate Mgmt, Kaufmannische Handelsschule, Switzerland.

HUDDLESTON, Teresa - Senior Consultant, Quality Assurance (Texas)

Teresa has more than 15 years of quality assurance, regulatory, manufacturing and clinical operations experience in the medical device and pharmaceutical industry. 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. Teresa's experience in regulatory affairs with Guidant 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. She applies this knowledge for the benefit of Emergo clients as she works with them to implement Quality Management Systems, perform audits and provide consultative advice on compliance issues. Education: M.S. in Biology, North Carolina Agricultural and Technical State University; B.S. in Biology and Minor in Chemistry, Winston-Salem State University.

JOHNSON, Mike - Director of Business Development (Minnesota)

Mike oversees Emergo's business development efforts and has more than 17 years experience in sales and marketing, with extensive knowledge of the medical device industry. In addition to establishing new client relationships, he works to ensure Emergo's brand is well known among industry professionals. Mike's knowledge of the device industry was gained during seven years he spent with industry leader Intertek as their National Business Development Manager. During his tenure there, he was instrumental in growing the company's medical device business into one of the top medical device testing labs and the #1 FDA 510(k) reviewer in the US. Mike has visited countless medical device manufacturers over the years, so he understands the regulatory challenges facing small and large companies alike. He has extensive knowledge of IEC 60601, quality management systems and FDA 510(k) requirements. Education: B.S. in Business Management and Communications, University of Minnesota.

LAUBACHER, Craig - Validation Program Manager (Texas)

LOH Ph.D., Evangeline  - Vice President of Regulatory Affairs (Texas)

Dr. Loh oversees regulatory consulting support for Emergo clients worldwide. In this role, she provides a wide variety of consulting support to clients including Technical File and Design Dossier preparation, CE Marking consultation, risk analysis consulting, classification determination and US FDA 510(k) preparation. 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, EU and Australia, she has worked on regulatory submissions in Canada, Korea, Taiwan, Japan, China and Hong Kong. Education: Ph.D., Department of Pharmacology, University of Texas Health Science Center San Antonio (UTHSCSA); B.S. in Microbiology, College of Agriculture and Life Sciences, Cornell University.

MAHER, Jessie - Regulatory Affairs Assistant (Texas)

Jessie helps ensure the smooth day-to-day operations of regulatory projects in the Austin, Texas office. She supports Emergo Group's Regulatory Team with coordinating regulatory submission documents, processing agreements, maintaining client regulatory documentation and registering medical and in vitro diagnostic devices with the Dutch Ministry of Health. Prior to joining Emergo Group, Jessie held positions that utilized her strong customer service skills and attention to detail.  Jessie also worked temporarily with the Peace Corps in Niger, West Africa, where she learned basic Zarma.  She is also proficient in French and has a basic knowledge of Spanish and working knowledge of Italian. Education: B.A. in Linguistics and French, Minor in Italian, University of Texas at Austin.

MAHONY, Lauren - Accounting Manager (Texas)

MALDONADO-HOLMERTZ, Elisa - Vice President of Business Development (Texas)

As the Vice President of Business Development, Elisa's job is to build market position by locating, developing, defining, negotiating and closing business relationships for Emergo Group. Her responsibilities include contacting potential and current clients and exploring ways to provide support to them. Prior to joining Emergo Group, Elisa worked within Clinical Research, Marketing & Sales, and Reimbursement for CRO, large pharma and  start-up medical device companies in USA, Belgium, Sweden, and P.R. China. Education: Certificate of Health Economics of Pharmaceutical and other Medical Interventions, European School of Health Economics; Diploma in Management, Henley Management College; B.A. in Zoology, The University of Texas at Austin.

McCOY, Kimberly - Senior Consultant, Quality Assurance & Regulatory (Texas)

As a Senior Consultant for QA and RA, Kimberly has diverse responsibilities. 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. Education: B.A. in Political Science and International Relations, Texas Christian University.

OAKES, Krista  - Senior Consultant, Regulatory Affairs (Texas)

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. Education: B.S. in Psychology, Brigham Young University.

POWELL, Julie - Vice President, Quality Assurance Consulting (Michigan)

Julie brings 30+ years of experience in the medical device industry to Emergo Group clients. In her role as Vice President of QA, Julie spends the majority of her time implementing ISO 13485:2003 and GMP compliant quality systems for medical device companies. Her expansive knowledge of European, Canadian and US FDA regulations, combined with her impressive ability to foster collaboration within companies for whom she consults, makes her Emergo Group's most requested consultant. Clients regularly tell us how much they and their staff enjoy working with Julie. Julie is also well-versed in the preparation of European Technical Files, US FDA 510(k) submissions and other international regulatory submission documents and helps companies with internal audits and training.

RETTINGER, Joe - Validation Program Manager (Texas)

SCHORRE, Chris - Vice President of Global Marketing (Texas)

As the Vice President of Global Marketing, Chris' job is to present Emergo to the world through a variety of online and offline media. His responsibilities include the planning, execution and measurement of strategic marketing plans. Among other things, he manages content and strategy for Emergo Group's nine international websites, blog and associated online advertising. Chris also writes and coordinates all printed communications including brochures, direct mail, magazine advertisements, articles and worldwide press releases. Prior to joining Emergo, Chris managed direct marketing for a division of Zurich Insurance and worked for several years as an advertising copywriter. Education: B.A. in Advertising, Michigan State University.

SENECHAL, Katie - International Projects Assistant (Texas)

Katie supports the International Liaison Manager by coordinating projects with Emergo Group's international offices. Her responsibilities in that capacity include assisting with administrative project management, maintaining the security and accuracy of client documentation, coordinating international consulting projects and serving as a liaison between clients and Emergo Group's international offices. Prior to joining Emergo Group, Katie worked with a real estate and contracting company where her responsibilities included development and administration of a database, interfacing with clients, report generation and oversight of other employees. Katie is from North Carolina, lived for two years in Hong Kong, is fluent in Spanish and has a basic working knowledge of German and Mandarin Chinese. Education: M.Sc. in Mechanical Engineering, University of Hong Kong; B.A. in Mathematics, University of North Carolina at Asheville.

SOBKOWIAK, Martin - Director of Finance (Texas)

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 Australia Pty. Ltd. and Jyton & Emergo Medical Technology Co. Inc. 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 ATM machines. His experience with large multinational firms gives him an understanding of complexities of running Emergo's international offices. Martin is fluent in German and English. Education: B.A. & MBA in Accounting & Finance, University of Paderborn, Germany.

TANG, Shelly - Marketing & Sales Assistant (Texas)

Shelly provides administrative support to the Emergo marketing and sales team.  She assists the Vice President of Global Marketing with website content management, reporting and analysis of marketing performance and direct mail coordination.  Shelly also supports the Vice President of Business Development and sales team with generating sales reports and CRM data management. Prior to joining Emergo, Shelly held positions that helped refine her customer service and analytical skills. Shelly has a working knowledge of Chinese and Spanish. Education: B.A. in Psychology, Southwestern University, Texas.

TONTINI, Caroline - Project Manager, North America (Texas)

As Emergo Group's Project Manager, Caroline is responsible for assigning, coordinating and scheduling all client projects for Emergo Group's consulting team.  Her central role keeps her in constant communication with both consultants and clients throughout the duration of each project and beyond. Prior to joining Emergo Group, Caroline worked in the document localization, construction and tourism industries where she gained diverse project coordination and planning experience and held regional management positions in homebuilding and retail operations. As a dual US/UK national who worked for 12 years in Paris, France, Caroline's international perspective provides a valuable understanding of conducting business on a global scale; she is fluent in French. Education: M.A. in Business and French, University of Edinburgh, Scotland.

VAN DER WOUDE, Michael - Chief Operating Officer (Texas)

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 firsthand experience running his own company and working for a leading multinational financial services company gave Michael a well-rounded understanding of the myriad challenges 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: M.A. in Business, University of Groningen, The Netherlands.

VAN DE ZANDE, René  - President & CEO (Texas)

As President and CEO of Emergo Group, René spearheads the international expansion of Emergo's operations and service offerings and provides guidance and support to its global divisions in Australia, Asia, Europe, North America and South America. Prior to founding Emergo Group, René served as Senior Commercial Specialist at the U.S. Mission to the European Union, during which he monitored and reported on European legislation, particularly European Directives under the "New Approach" (CE Marking), including the Directives related to medical devices and in vitro diagnostics. He also participated in the TransAtlantic Business Dialogue (TABD), providing support to the late US Secretary of Commerce Ron Brown and US Ambassador of the US Mission to European Union, the Honorable Stuart Eizenstat. René has published numerous articles on medical device regulations and related issues and is co-author of a series of publications on European product legislation for the U.S. Department of Commerce and the National Institute for Standards and Technology (NIST). He is a frequent guest speaker on European regulatory affairs related to medical devices and in vitro diagnostics. Education: Post-Graduate Degree, Johns Hopkins University School for Advanced International Studies (SAIS), M.A. in Contemporary History, University of Nijmegen, The Netherlands.

VINCINS, Richard - Senior Consultant, Quality Assurance & Regulatory (Florida)

Richard brings a wealth of FDA and European regulatory expertise to Emergo, experience gained from 17 years of 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 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; Associate of Science in Chemical Engineering, Salt Lake Community College.

VORDTRIEDE, Mark - Senior Consultant, Quality Assurance (Missouri)

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 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. Mark is well versed in ISO 9001, ISO 13485, FDA GMP, TS 16949, AS 9100 and ISO 14000. Education: B.S. in Civil/Architectural Engineering, School of Engineering, Washington University.

WARE, Ph.D. Sarah - Market Researcher, USA (Arkansas)

Sarah has past medical and research experience in hospitals, physician's clinics and laboratories. In her current position as a Project Manager with EDM Services, she interacts with international clients to provide individually tailored reports containing US market information and suitable distribution partners. Before joining EDM, Sarah spent several years working in a regional hospital and physician's clinic. She is fluent in English and Dutch.  Education: Ph.D. in Genetic Research from Wageningen University, The Netherlands. Ph.D. in Genetic Research from Wageningen University, The Netherlands; M.S. in Genetic Research, University of Arkansas; B.S. in Biomedical Research, University of Arkansas.

WHITE, Lori - Client Support Manager (Texas)

With a background in records management and executive administrative support, Lori possesses many skills that make her well-suited in her role at Emergo. Prior to joining our team, Lori was Office Manager and Executive Assistant for Clear!Blue LLC in Michigan. Here, she organized and executed team events, established vendor relationships and provided creative input to account managers. Lori also has several years of experience as a Sales/Administrative Supervisor and Records Manager for a well-known ISO Registrar serving the automotive industry. Among other things, she worked to streamline the records department, prepare RFPs, assist in proposal/contract modifications and manage the QS-9000 (predecessor to TS 16949) probation process for clients.  Education: B.S. in English (Professional Writing), Eastern Michigan University.