Niels Festjens

Medical Device Quality Assurance & Regulatory Affairs consultant

Belgium, EU

Partner to Medical Device manufacturers and suppliers to support the implementation and maintenance of 21CFR820 (FDA-USA), ISO 13485:2016 and MDR 2017/745 (EU) compliant Quality Management Systems,
and with obtaining market authorization in Europe and the United States (CE marking, 510(k), ...).

When your organisation makes it next move in the field of Medical Devices, regulations can be overwhelming. Building up knowledge and confidence with respect to quality assurance and regulatory affairs internally takes time and is anything but a straightforward process. Not to mention hiring a full-time quality or regulatory affairs manager to ensure risk, cost and compliance are addressed from the start might not fit into your business plan just yet.

Using my experience and knowledge gained as Quality Manager at one of Belgium's leading innovation companies, combined with an analytical, cost-efficient mindset on an industrial engineering and software development background, I believe I can help your company to overcome that hurdle.

My services range from ISO 13485/FDA gap analysis up to the implementation of your ISO/cGMP compliant QMS, compilation of 510(k) submission/CE technical file, as well as long-term operational projects like interim Quality Management. For each project, I strive to find a solution tailored to your company's culture, its strategy and its ambition and aim to become your collaborative partner in QA & RA.

In the end, compliance is important to every medical device firm but delivering high quality product in a cost-efficient matter is the real driver.

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