Daan Pelgrom

Daan Pelgrom

Business Development Manager Europe

Daan is responsible for sales in Europe and developing Qserve’s activities further into the European market. Daan’s solid understanding of the medical device market and the EU approval process at Notified Bodies help our customers to find Qserve and navigate through the increasing complexity of the EU regulatory landscape.

Daan is a pragmatic, driven and knowledge-able commercial manager, though with a solid background in auditing, QMS implementation, trouble shooting and change management.

The key expertise areas of Daan

•  Detailed understanding of Notified Body expectations regarding MDR 2017/745, IVDR 2017/746, MDD 93/42/EEC, IVDD 98/79/EC, AIMD 90/385/EEC and ISO 13485 / ISO 9001 compliance. 
•  Detailed knowledge of regulatory schemes such as Medical Device Single Audit Program (MDSAP), US FDA 510k, INMETRO (BRA), PMD Act (JP), TGA (AUS) and Technical Cooperation Program TCP (TW). 
•  Experienced with regulatory strategy assessments and complex project management involving high risk devices & systems: deep brain stimulation, neurostimulation/-modulation, cardiovascular, endovascular, ophthalmic, injectables, wound care, imaging (MR, CT, X-Ray, Ultrasound, SPECT), software, animal tissue containing implants, drug-device combinations, hematology, clinical chemistry, immunochemistry, infectious immunology.
•  Cross-cultural Business Development.
•  Key Account Management of globally operating multinationals.
•  Customer Relations, Marketing & Communication.

Before Qserve

Prior to joining Qserve as Business Development Manager Europe in February 2020, Daan had different commercial roles at DEKRA (former KEMA) Notified Body, where he was responsible for business development in the NW-EU region. He was a member of the operational management team and change board.

Prior to DEKRA, Daan worked in the Food industry where he had different roles within QA / QC. The Medical Device and IVD field very much appealed to him and the passion for regulatory, clinical and quality related topics within MedTech never went away.

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