Pedro Eerdmans

I’m available to support medical device companies, venture capital groups, investment banks, and family offices in gaining a comprehensive understanding of the MedTech landscape. (non-commercial) This includes: Clinical evidence requirements for Europe and the US Therapy adoption pathways and reimbursement challenges Strategic guidance on where to conduct clinical studies, including first-in-human trials Evaluating whether to partner with a CRO or build an internal clinical department With hands-on experience across clinical, regulatory, and market access domains, I help stakeholders navigate complexity and make informed decisions that accelerate innovation and adoption.

• Provided clinical and regulatory strategy advice to companies in the US and EU. • Developed development roadmaps leading to successful market releases. • Participated in FDA presub meetings to advise on next steps.

• Led clinical focus and designed studies for market approval in US and Europe. • Transformed R&D driven environment into a medical device company. • Contributed to funding discussions for continued development.

• Provided clinical guidance for therapy development and reviewed medical messaging for CE marking process at PRECISIS GmbH. • Supported therapy rollout post-CE certification and sign off on manufacturing improvements and company expansion.

• Led global clinical studies at MedAlliance Swiss Medical Technology, resulting in a landmark acquisition by Cordis for USD 1.135 billion. • Obtained approval and initiated 3 IDE FDA studies, along with starting two large post-market studies with 740 and 3326 patients. • Clinical program played a key role in the successful acquisition by Cordis.

Manage a team of internal clinical experts and 80+ external consultants (physicians) to evaluate clinical evidence (data) presented by manufactures for initial or renewal CE certification. Provided both Dekra Notified Bodies with medical expertise during CE certification, vigilance cases, and device recalls.

Managing the Notified Body with offices in Netherlands (HQ), USA, Israel, Japan and China. VP of business line Medical

Global responsibility of all neuromodulation studies, US responsibility of the cardiac studies. Managing the clinical team in the US, based in the US HQ Houston.