Peter van Keulen - Senior Consultant, Quality Assurance & Regulatory

Peter is responsible for implementing FDA QSR and ISO 13485 compliant quality systems for medical device and IVD companies. He assists companies with internal and supplier audits and regularly performs employee training on CE Marking, ISO 13485, ISO 14971, FDA cGMP and internal auditing.

Peter has many years of experience managing the compliance requirements of the Medical Devices Directive (MDD), In Vitro Diagnostics Directive (IVDD), and Active Implantable Medical Devices Directive (AIMD) and other directives for CE Marking in the European Union. Peter is particularly strong in development of validation protocols (installation, operational, and performance qualifications); gap analysis (determining gaps in existing validation vs. risk assessment, defining corrective measures) and creating validation documentation. He has an in-depth knowledge of risk management development and implementation in accordance to ISO 14971.

EXPERIENCE:

Sr. Quality & Regulatory Engineer, WA Cardio Control BV - Welch Allyn subsidiary (2004-2006)

• Responsible for all aspects of QA/RA management, as well as handling priorities, balancing business objectives and (technical) quality requirements.
• Performed product quality analysis, reviewing data from incoming inspection through warranty and post warranty field performance.
• Perormed numerous internal audits with focus on design controls and software verification and validation, gate release audits, production audits, and Corrective and Preventive Actions (CAPA).
• Managed the non-product software validation program, process validations, Master Validation Plan.
• Aligned business unit quality system procedures with company global QMS.
• Assisted product development team in guiding and monitoring their compliance with the Quality Management System, based on 21 CFR Part 820 and ISO 13485.
• Contributed to the design control process, including risk management, verification, validation, design reviews and transfer to production.
• Maintained ISO 13485 registration activities (i.e. CAR process, document control, internal audits and external communication and coordination with outside regulatory agencies etc.) and in preparing technical documentation (CE & FDA).
• Provided technical leadership to the product development team concerning the establishing of design verification and validation strategy and plans
• Product and component reliability plans; clinical and field trial and extended customer use plans.
• Prepared software verification and validation reports.
• Responsible for worldwide regulatory submissions: CE marking, FDA 510(k), Canada , etc.
• Supported product development teams with regards to design controls.
• Prepared Design History File and DMR documentation, product specifications, risk management, verification and validation and clinical studies.

Project Manager for CE Compliance of Medical Devices, KEMA Medical (2001-2004)

• Managed staff of 10 people auditing and reviewing technical documentation of medical devices for KEMA Medical, a Notified Body under the European directives regarding the Medical Devices (MDD), the Active Implantable Medical Devices (AIMDD) and the In-Vitro Diagnostic (IVD) directives.
• Project leader responsible for assessing technical files and design files to verify and ensure compliance with CE regulations.
• Reviewed safety test protocols, test reports and other sources of independent judgment, and subcontracting arrangements.
• Wrote reports, performed on-site quality system based audits, audited manufacturers facilities to the requirements of the Medical Directives (AIMDD, MDD, IVD) and ISO 13485/88 and EN46000 for European market access.
• Performed third-party audits - i.e. auditing to CAN-ISO 13485 under the CMDCAS program for Canadian market access and reviewing 510(k) files on behalf of the FDA for access to the American market.
• Coordinated activities within each CE-subcontract to ensure that it is (within the scope) completed on time and within cost limits.
• Developed/presented training courses on risk assessment, software control, and safety systems.

Modeling Consultant, Thales Netherlands BV (1994-2001)

• Major tasks comprised activities related to and being responsible for integration of many existing and to be developed simulation models.
• Developed, revised, and maintained quality standards (SOPs, SEI/CMM) for major modeling activities and numerical products.
• Planned for long term investments and structured model development activities.
• Involved in the development of software in order to simulate operational behaviour of infrared and radar sensor systems including interconnecting data hand-over and environmental conditions.
• Set up and performed analyses to predict consequences in design as well as performing feasibility studies.
• Developed simulation programs and its infrastructure, including the actual programming activities; evaluation of system performances under test conditions and during acceptance testing.
• Performed in-depth image analysis and 3D-reconstruction studies and conducted study reports and other scientific reporting activities.
• Participated in a number of feasibility studies regarding software (model) development and infra-red detection (TNO-FEL, NATO, industrial consortia, etc.).

Research Scientist, Interuniversitair Cardiologisch Instituut Nederland (1986-1993)

• Employed in Departments of Cardiology; Paediatrics; and Thorax Surgery of the Academic Hospital St. Radboud, Nijmegen.
• Designed new methods and equipment in order quantize, diagnose and verify the blood flow in the heart and the greater body vessels using ultrasound techniques.
• Evaluated various quantitative methods in the field of image analysis (static and real-time), 3D tissue reconstruction and (cardiac) tissue characterization (includes: X-ray, radioisotope imaging).
• Planned and (partly) managed clinical evaluation studies.
• Guided physicians and staff members on new technical developments and technical issues related to instrumentation and signal-acquisition, signal analysis, handling and storage of digital information (PACS, DICOM), software engineering, database applications and bio-statistics.

System Analyst, Centre Education Information Technology, University of Twente, The Netherlands (1984-1986)

• Participated in design and realization of voluminous, complex and fast mutating databases (using Oracle) with a strong emphasis on research. Responsible for all prototyping activities and many aspects of system design. Accountable for software implementation.

AREAS OF EXPERTISE:

Medical Devices:

• Software used in devices.
• Extensive knowledge of: Fortran, C, C++, unix-shell scripting, perl, java on Unix workstations (Sun/Solaris), pc (Windows en NT), Vax/VMS. Real-time Unix and other embedded systems; and programming environments: Matlab/Simulink, PV-Wave, IDL, Mathematica, etc.; multiprocessor and high performance computing and client-server systems.

QA & RA:

• Conducting audits of quality systems to ISO 9000, EN 46001, ISO 13485, as well as associated relevant standards (ISO, IEC, EN, UL, AAMI).
• Software validation, developing and auditing software controls in accordance with Tick-IT requirements, CMM (SEI), 21-CFR-Part11 (FDA), ISO 9000-3 and IEC 60601-1-4.
• Risk management.
  

CERTIFICATIONS:

• Certified Quality Assessor (Europe, USA and Canada), KEMA KRQ-USA.
• Certified Quality Assessor (ISO 9001 and EN 46001), KEMA Quality, Arnhem.

EDUCATION:

• Masters in Applied Physics, University Twente, The Netherlands.

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