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.

I am also a board member of the RAPS Netherlands Chapter, organizing and contributing to subject matter discussions.

 

Pieter de Vries

I am a principal consultant in the medical device industry with a vast experience in EU and USA regulations and an expert in ISO 13485 certification.

I have worked almost 10 years for Notified Body DEKRA Certification (formerly KEMA Quality) as a Project Manager, managing accounts that need regulatory certifications. I performed technical documentation reviews, as well as quality system audits as an audit team leader. I conducted audits in many areas of the world, including Europe, Asia, Middle East, Africa and USA. I acted as global product expert for ISO 13485 and the Canadian CMDCAS program. As Certification Manager, I made decisions on granting, suspending or withdrawing certifications.

Before that, I have worked in several positions in the medical device industry (R&D, Manufacturing and QA/RA) and in a university hospital. My background is biomedical engineering and my expertise is with active medical devices (e.g. CT, MR, Cardiovascular X-Ray, Lasers, Ultrasound, Patient Monitoring, Rehabilitation and ENT), including software (stand-alone such as PACS, as well as embedded software) and IVD instruments.

 

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

 

 

Hester Hasper

I am a senior consultant in the medical device industry with experience in the field of medical device regulations as well as pharmaceutical industry.

After 5 years in method development and trouble shooting for QC and drug substance manufacturing at a pharmaceutical company, I worked at Notified Body KEMA Quality / DEKRA for 2.5 years. I served clients ranging from small startup companies in technology hotspots like Israel to large multi-site high risk device manufacturers.

In addition, I was trained as biological safety reviewer for high risk medical devices. Furthermore, I was involved in several projects for which consultation at national health authorities was required for the drug substance part of drug-device combinations.

After working at DEKRA, I was employed for 3 years at a pharmaceutical company as a team lead of the customer and regulatory support services team.

I can fulfill various functions, like e.g. QA/RA manager, Project manager/Expert member in D&D projects for the above mentioned areas of expertise and internal or supplier auditor.

 

Menno Verheij

I am a senior consultant in medical device design, quality and regulation. I have experience in the product and process design of active medical device development and maintenance.
My professional career started in 1998 and within healthcare since 2008. My educational backgrounds are in software engineering, communication and business administration. I have fullfilled many roles in my career as computer programmer in a vast amount of languages and environments, application manager, project lead, information-analyst, process-analyst, quality assurance officer and consultant.

I have a practicable result-oriented way-of-working, well analytical skills and I can flexibly cope with changing situations. My fascination is to create and implement innovative, yet lean, quality management systems with focus on -agile- product development processes. And to help setting up regulatory strategies, technical files, and other pre and post market regulatory activities in the medical device domain.

 

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.

 

Herre de Jong

Throughout my professional career of over 25 years in the medical device industry I bring a broad experience regarding quality management systems and conformity assessment (submission) processes . In the role of consultant I can help organizations with any challenge throughout the lifecycle of a medical device or the quality management system and the relevant regulatory requirements.

 

It’s my philosophy to establish simple, risk based and logical quality management systems that are clear at point of use, prevent device and regulatory risks, improve organizational performance and reduce time to market regarding regulatory submissions.

 

My experience and knowledge is based on:

  • Quality Assurance and Regulatory Affairs positions within medical device companies (active and non-active devices);
  • Auditor and technical file reviewer at a notified body for CE-marking of medical devices; and
  • Consultancy services provided within medical device companies and their suppliers.

Robin Barwegen

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

I have worked as QA/RA Manager for an innovative start-up that developed a class III medical device (under MDR 2017/745) including hardware and software. I had an active role in the design and development process by conducting design reviews and approving design documentation such as design specifications, detailed designs, test protocols and test results. I have developed ISO 13485 compliant QMS's, including the requirements of the different regulations in the world.

 

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.