What does the community offer
A VOICE OF START-UPS – INNOVATORS
- Annual pulse report compiling intel on the opportunities and challenges related to CE marking based on feedback provided by market operators (esp. start-ups/ SMEs).
- Opportunities to interact and provide feedback to EU institutions on EU initiatives.
- Feedback from the NoBoCap Platform on a quarterly basis regarding unanswered questions and comments, open applications, and other community-related content.
A CAPACITY FOR EUROPE’S REGULATORY ECOSYSTEM
Training for people in regulatory functions or seeking to enter into a regulatory role within a Notified Body or Market Operator.
Connecting people within the HealthTech and MedTech regulatory ecosystem in Europe.
A BACKBONE SERVICE PLATFORM
• To obtain the KEY (MDR/IVDR applicable code(s)) and be matched to Notified Bodies designated to certify your specific technology.
• To obtain first-hand updates on the latest EU Legislative initiatives (Horizontal and sector-specific) of the changing regulatory environment in Europe and guidance to address specific issues.
• To interact directly with a network of supportive and knowledge partners to foster the creation of quality dossiers for timely conformity assessments. Nobocap will also offer c-level information session to define investment and resource needs to address regulatory requirements.
• To Interact with Peers, foster best practices and enable direct interaction with key players and initiatives of the implemented regulatory ecosystem and the EU services offered.