Interview with Qserve's consultant Sonja van der Meer
1. Tell us a bit about yourself.
After earning my BSc in Histo- cyto and pathology, I started working at the University of Leiden, in the biomaterials department, with my own project in the development of a biodegradable bone implant.
This department founded a spin-off company, performing biological safety testing, where I worked as a project manager. After that, I worked for a Notified Body as Lead Auditor and Technical File reviewer for a year, but I missed being able to provide advice and guidance to customers. That is why I joined Qserve.
2. What does a typical Qserve working week look like?
For me, a typical Qserve working week does not exist, since every week is different. For some customers, I provide structural support as interim QA or RA manager. Often, I am asked to review technical documentation, help with Notified Body communication, perform audits, write reports or provide support in other quality or regulatory issues.
3. How would you describe your work experience as a Quality and Regulatory Consultant with Qserve?
Because I joined shortly after the founding of Qserve, I have experience in almost all services within the portfolio of the company. I enjoy the variety of requests and the never-ending learning experience. This is related to both the changes in standards and regulations as well as the broad spectrum of products with which I work.
4. What is your specialization?
My specialization is Biological Safety Evaluation. As a technician I have conducted chemical, mechanical and toxicological safety tests. As a project manager at a biological safety test facility, I wrote test plans and reports. As technical file reviewer for a Notified Body, I have reviewed biological safety data and I have been a member of the NEN Committee for biological safety evaluation. With this background, I am familiar with all aspects of Biological Safety Evaluation.
Manufacturers are aware of the ISO 10993-series, but they are not familiar with the variety of tests available for each endpoint to address. In selection of tests it is essential to consider the intended use of the product. Too often, the most commonly used tests are selected and failing a test is considered as evidence of a material to be unsuitable.
My knowledge is useful for manufacturers designing and developing new materials, or in case of new application for known materials.
I also provide support in the selection of tests with the intention to limit the use of animal tests to a minimum. Additionally, I provide support in justification to refrain from performing additional tests based on available data from predicate devices or literature.
5. What do you hope your position contributes to the team?
The Qserve team is growing very quickly and I enjoy the fact that it is a combination between growth in knowledge and young people who are eager to learn. I strive to support my colleagues in becoming good consultants, both in transferring my knowledge and in effective communication skills. Lastly, I am excited to learn from my colleagues.
6. Anything else you would like to share with us?
The slogan of Qserve has always been “the practical approach” and I think this is a core value to keep in mind. Standards and regulations are becoming more comprehensive, which can lead to overcomplicating things. More (stringent) regulations do not always contribute to the product quality. I hope to contribute by keeping the focus on the quality of products and remaining down to earth in finding answers to challenging questions.
For more information, please read her profile: