Medical devices - IVDR - Pharmacovigilance - put your trust in a save pair of hands: Our services for medium-sized medical technology, in-vitro diagnostics and pharmaceutical companies: - Financing of development projects, regulatory approval according to EMA-MDSAP-FDA and international market requirements. - Process optimization in production and logistics with conversion to the EU Medical Device Regulation (MDR) We prepare the required technical documents for a successful MDR / IVDR and ISO13485 certification together with your experts - EUDAMED registration and UDI upload for medical devices We register your company with EUDAMED and arrange the UDI upload according to MDR Article 27 and Annex VI - EU Authorized Representative and UK Responsible Person We take over the task of the authorized person in the EU and in the UK including the preparation of all required documents. - Post Market Surveillance and Periodic Safety Update reports for medical devices, IVDR and medicinal products Market surveillance and contact point for product and adverse event inquiries - QPPV, Medical Advisor and PHARMACOVIGILANCE QPPV/Stage Plan Officer function, MedDRA reporting of ADRs, preparation of Period Safety Update Reports (PSUR): we help! - FDA for medical devices and pharma/biotech including clinical trials. For approval in North America we prepare 510k documents and Drug Master Files and accompany clinical studies Interesting for you - Feel free to contact us! regulatory@euswissmed.com