19.10.2025
Best Practice Pathways to Market Access for Your Medical Device
Navigating regulatory requirements and achieving timely certification is critical for medical device manufacturers seeking access to international markets. From meeting MDR/IVDR requirements in Europe and securing ISO 13485 certification, to leveraging programs like MDSAP and aligning with regional testing schemes, a well-planned approach can help avoid costly delays. In this session, BSI experts will outline best practices for engaging with your Notified Body, sequencing certifications, and preparing technical documentation effectively to enable effective market access.