About us - Team

Medical Device Project B.V. employs people with expertise in project management for the design and development of medical devices, set up, writing and maintenance of Technical Dossiers and Design History Files, product and process risk management, clinical evaluation, validation of processes, quality management system (ISO 13485) implementation, auditing, training & coaching, and have technical knowledge. As a result of the buildup of our knowledge we serve all types of device manufacturers.

For all our team members, you can find an overview of their expertises below. A more detailed description is available on request.

Jeannette van Loon

I am a principal consultant for medical device manufacturers. I am holding a Ph.D. degree in biomaterials and wrote a thesis on biocompatibility testing of degradable polymers for medical devices.

At the time the Medical Device Directive 93/42/EC was launched in Europe I was senior standardization consultant at the Dutch Standardization Institute (NEN) and as intermediator between industry, authorities, research and the clinical field responsible for national, European and international standardization processes in the field of medical devices, biological safety evaluation, sterilization evaluation, risk management and quality management systems.

I have been COO at a test- and research laboratory specialized in biocompatibility and biological safety testing of medical devices. Notified Bodies contract me as external reviewer of technical dossier parts (e.g. biological safety evaluation) or as external QMS auditor.

Depending on your needs I can act at different process levels in your organization and can fulfill the function of the Quality/Regulatory Affairs Manager, Project Manager of the Design & Development process or as Expert Member of the D&D project team. I can fulfill similar roles at suppliers of e.g. raw material or device component suppliers, contract manufacturers or service providers.

Robert van Boxtel

I am a principal consultant in the medical device industry with a vast experience in EU and USA regulations.

After 8 years in the medical device industry in R&D and manufacturing, I worked more than 7 years at Notified Body KEMA Quality / DEKRA. As Sr. Project manager and account manager I was responsible for quality system audits and dossier reviews under EU Medical Device regulations. Additionally, as product expert FDA 510(k) 3rd party accreditation program, I was responsible for the internal review process and performed file reviews myself, including contacts with the FDA. Over the years, my client database developed to include large accounts and small startup companies in the technology hotspots in the world (USA, Israel, EU). Specific focus on drug-device combination products, including the required consultation procedures with the drug authorities.

Aside from supporting your company's QMS or build your dossiers for regulatory submission, I am a trainer on the EU Medical Device Regulations, ISO13485:2016, Risk Management and many other subjects.

Recently I also trained several hospitals on the impact of the new EU MDR and IVDR for their organization.

As volunteer, I am a board member of the RAPS Netherlands Chapter, organizing and contributing to subject matter discussions. Additionally, I am Vice Chair in RAPS European Council, and in two program committees of convergences organized by RAPS in Europe.

Ineke van den Brink

I am a senior consultant in medical device development, production, quality, regulation and standardization. Previously I have worked as project manager, senior developer and trainer in a tissue engineering company. Aside my work in design and development processes, I was involved in setting up laboratories under GLP conditions, setting up clean rooms and production processes under GMP conditions, equipment qualification and validation, process validation and Quality Management Systems. I was responsible for specific Design History Files. Besides that I have worked in a biocompatibility and biological safety testing laboratory for medical devices.

I started my career in a university research center focusing on medical device development, tissue engineering and biomaterial-tissue interactions, using cell culture techniques, biochemical assays, animal testing and histological and electron microscopical evaluation techniques. My approach is to look at design, development, production and quality processes within a company from a risk-based, practical, feasible and solution-oriented perspective.

There is a variety of functions I can fulfill, e.g. QA/RA manager, Project manager/Expert member in D&D projects, Validation engineer, Auditor, and Facility manager

Fabiènne Péters

I am a senior consultant in the medical device industry, providing consulting services for QMS (ISO13485/ CFR820), product files and regulatory submissions.

I have over 15 years’ experience in the medical device industry. This includes 12 years at an airway management company, working as Head QAC/RA Officer, Supply chain Manager, Project Manager and Sr. Project Developer. Previously, I work for 5 years in a tissue engineering company (under GLP/GMP) as Sr. R&D technician and QC supervisor.

Prior to working in the medical device industry, I started my professional career in a Chemical company as an Analytical R&D technician, and later as a Polymer Researcher in a Food & Biobased company.

I can fulfill various functions like e.g. QA/RA manager, Project manager/Expert member in D&D, Production and Supply chain projects, QC manager and Auditor.

Leon Assink

I am a senior consultant in the medical device industry, with experience in both medical devices and in vitro diagnostic devices.

I have worked for an IVD company with List B and self-certifiable devices (under IVDD 98/79/EC) and Class I and Class II devices (USA). As integral project leader R&D I was responsible for development of new products in collaboration with instrument manufacturers. In the role of Product Change Control Manager I was responsible for maintenance of the Design History File and performing Change Control on products released into the market.

For a Medical Device company I have worked as Quality Assurance officer. In that role I have had an active role in the implementation of the design and development procedure, including IEC 62304 for software and ISO14971 for risk management.

Vincent van der Meer

 I am a senior consultant in the medical device industry and have always had a high interest in biology, especially the medical biology, since I’ve studied Life Sciences. While I initially started my career as an IT consultant, I moved to the Medical Device industry over 7 years ago because I was intrigued by the challenges one of my clients, who was a Medical Device manufacturer, faced in their Quality Management System as well as regulatory challenges regarding their products.
Since then, I have been using and broadening my skills in several R&D- and QA/RA positions for Medical Device product development (DTM, DHF, Technical Dossiers), manufacturing & sterilization processes (DMR, infrastructure, validation) and numerous quality- and regulatory processes related to ISO 13485 (distribution, traceability, PMS, UDI’s, change control, etc), all related to the Medical Device Directive and (transition to) the EU Medical Device Regulation.

I have worked with a variety of products, from self-certified class I endoscopy disposables, class IIb advanced wound dressings up to high-risk (class III) soft-tissue implants in several positions, from QA/RA support to QA/RA specialist and more recently as Director QA/RA and R&D.

With a history in IT, I have an eye for using efficient and/or automated systems for QA/RA challenges in both small and large companies. I analyze and translate challenges in understandable and workable solutions.

Henk Boekholt

 I am a senior consultant in the medical device industry with experience in active medical devices and a fascination for new technologies.

I have a background in analytical chemistry (BSc) and information technology (MSc). During my previous career quality management and quality related processes played an important role. The first career steps were made as deputy quality manager (at a STERLAB accredited laboratory) where I was application owner of information system(s). The application of Information technology to support business processes has kept my interest and I switched to the information technology services industry. I worked on projects where quality management, design, verification and validation processes needed to be implemented and executed. This in different sectors, food, telecoms, banking and the medical device industry.

During my previous work in the medical device industry I had the opportunity to gain in depth experience in the (digitization of) manufacturing processes of implantable devices. I could add value in the quality assurance of software development processes as well as providing valuable support to capture and elicitate the requirements (URS). My formal responsibility was to assure the complete lifecycle of the project and its documentation deliverables (implantable medical devices company).

I have an eye for the broader picture of a problem and an eye for detail and find it rewarding to support organisations implementing QA systems within software development for medical devices (e.g. ISO 62304, ISO 13485) or to support with non-device software validation projects.

Rutger Kuipers

I am a senior consultant in the medical device industry, providing consulting services for QMS’s, product files and regulatory submissions.

I have over 25 years’ experience in the medical device industry and (bio) pharmaceutical companies. I have worked in Quality, Regulatory and project management roles for various companies. I have worked on all general QA-activities (like batch release, change control, validation, CAPA, doc-control and internal audits). More recently I have focused on supplier audits and risk-management. My experience is mainly related to non-active devices.

I have experience with the Quality aspects of outsourced operation-activities (manufacturing, warehousing and distribution). To improve my project management skills, I have become a lean six sigma green belt.

I can fulfill or support various functions like QA/RA manager, Project manager/Expert member in D&D, Production and Supply chain projects or Auditor.

Bart Jungerius

I am a senior consultant in the medical device and in-vitro diagnostic industry, providing consulting services for the set up and implementation of quality management systems, product files and regulatory submissions.

I have a MSc degree in Molecular Sciences, providing me with an understanding in a wide area of topics in biology, chemistry and physics. I hold a PhD degree in molecular genetics and delivered a thesis on development and implementation of genotyping methods.

I have over 15 years of experience in medical devices and IVDs working in various companies. In the field of IVDs, as R&D manager I was responsible for Design and Development of IVD products including change control and maintenance of all technical documentation and I was actively involved in product registrations worldwide and improvement processes. As QA/RA manager I was responsible for QMS implementation, ISO 13485 certification, CE and IVDR compliance.

As QA/RA specialist in medical device companies with various medical devices (e.g. equipment, device systems, invasive devices, implants and accessories, class I-IIb), I supported new product developments by providing and maintaining e.g. regulatory strategies and STED files, supported design changes and improvement processes. Also, I was involved in the MDR transition and I supported product registrations worldwide.

Jelle Schrauwen

I am a senior consultant in the medical device industry, providing consulting services for QMS’s, product files and regulatory submissions.

I have an MSc degree in biomedical engineering and a PhD in medical engineering. This gave me a solid foundation in a wide range of engineering and physics topics that are applicable to the medical device industry. It provided me with an understanding of scientific and clinical research principles that are essential for medical device development.

Before joining MDProject I worked in the medical device industry for more than 7 years, bringing new medical devices for interventional cardiology to market. I worked on product development, following the design control principles according to the MDR and FDA regulations, and ISO 13485. I have headed Clinical Evaluation processes towards market approval, set up Post Market Surveillance, designed and executed validation studies, and supported Risk Management. As such, I helped to create Technical Documentation for successful CE marking and 510k submissions.

My work experience gave me a thorough understanding of applicable regulations in the medical device industry. My focus is to untangle complex problems and provide pragmatic and understandable solutions to Regulatory and Quality challenges.