Direct expertise in Q&A cycles with Notified Bodies.
Former Senior Reviewer at TÜV SÜD. Specialist in Class III implants.
Former Intertek/SGS reviewer. 20 years of Notified Body experience.
Site qualification and ISO 14155:2020 compliance.
30 years in biometry. Architect of the MILO EDC platform.
Chems identified a critical gap: manufacturers needed a partner who understood both clinical reality and the strict expectations of European regulators.
He architected Eclevar’s therapeutic departments, piloted MILO EDC, and established global regulatory corridors from the EU to Japan (PMDA).
He leads regulatory strategy with first-hand experience in Notified Body questioning cycles. Specialist in structuring technical files for high-risk devices (Class III).
His anticipatory methodology systematically reduces Notified Body review cycles, accelerating time-to-market.
30 years of experience in biometry. Lead architect of MILO EDC and co-author of the EU MDR biometric activities framework. Expert in 21 CFR Part 11 compliance and FDA/EMA inspection readiness.
A former reviewer at TÜV SÜD, he has examined hundreds of clinical files for implants. He builds PMCF programs and CER reports that he himself would have approved as a reviewer.
Former technical reviewer for Intertek and SGS. She knows precisely what triggers questions or major non-conformities during dental technical file audits.
Expert in clinical evaluation methodology for cardiovascular devices and complex implants. His specialty: building traceability matrices and Article 61(4) equivalence architectures.
He leads operations in Tokyo and bridges the gap between European MDR requirements and Japanese PMDA expectations. Expert in Foreign Manufacturer Accreditation.
He supervises our ISO 13485:2016 certified QMS. His rigor ensures that every study and dataset is audit-ready from day one.
Strategic point of contact for cardiovascular programs. Expert in KOL engagement and presence at conferences like EuroPCR.
Architect of MILO EDC. He ensures cloud security and digital innovation to make structural non-compliance impossible.
