Regulatory expectations are evolving fast. Even the most experienced quality and regulatory leaders need clear, reliable guidance in this complex arena.

With BSI, you will get the expertise, clarity and assurance that help you navigate European and UK medical device requirements with confidence.

When you join the 15th Annual Medical Device Roadshow, you step into a space designed for you - the regulatory affairs and quality assurance community committed to delivering safer, compliant and innovative medical technology.

This in person event gives you:

• Direct insight from a world-class Notified Body.

You will hear the latest best practice, expectations and lessons learned from the first Notified Body designated under the MDR (EU) 2017/745.

• Guidance from experts who understand your challenges.

With 1,000+ technical specialists and internal clinicians, BSI provides the clarity and support you need to meet regulatory requirements and maintain timely market access.

• Practical clarity across European and UK routes.

Gain clear guidance from BSI The Netherlands (2797) for CE marking and BSI UK (0086) for UKCA conformity assessments.

Our team of 1,000+ medical device experts - spanning clinicians, technical specialists and auditors- supports global market access through ISO 13485 certification, CE and UKCA approvals, product testing and standards development.

Agenda

Have Questions? 

Email: us.medicaldevices@bsigroup.com

Phone: +1 888 429 6178