Hear from a world-class Notified Body
BSI hosts our 14th Annual European Medical Device Roadshow for the medical device manufacturer regulatory affairs, quality assurance and related consulting community.
Join us in person for our Medical Device Roadshow exclusively focused on addressing European medical device regulatory and quality assurance requirements.
BSI will be sharing our current experiences, best practice and expectations from the perspective of the first Notified Body designated under the MDR (EU) 2017/745. BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the UKCA scheme.
BSI Regulatory Services consists of a team of over 1000 professionals including technical experts and internal clinicians competent in encompassing the full range of medical devices and management system standards. Our services include system certification to ISO 13485, CE and UKCA certification, product testing, and standardization to support global market access.
Our mission is to ensure patient safety while supporting timely market access to medical technology in a sustainable manner.
Agenda
| 8:30 am - 8:45 am | Welcome and Intro |
| 8:45 am - 9:45 am | Hot Topics - EU |
| 9:45 am - 10:15 am | Legislative State of Play - UK |
| 10:15 am - 10:30 am | Coffee Break |
| 10:30 am - 11:00 am | MDR: Electrical Safety and Cybersecurity Requirements |
| 11:00 am - 12:00 pm | 2024-2025 Year in Review: EU AI Act and ISO 42001 |
| 12:00 pm - 1:00 pm | Lunch |
| 1:00 pm - 1:30 pm | How MDSAP can help you |
| 1:30 pm - 2:15 pm | Innovation Pathways: What is the current state of play? |
| 2:15 pm - 2:45 pm | BSI services (structured dialogue, TDR review timelines, transfer) |
| 2:45 pm - 3:00 pm | Coffee Break |
| 3:00 pm - 3:50 pm | Most common clinical questions raised during MDR assessments |
| 3:50 pm - 4:00 pm | Wrap up |
Locations/Date:
| Monday, November 3rd | Santa Clara, CA | |
| Wednesday, November 5th | Minneapolis, MN | |
| Friday, November 7th | Burlington, MA |
Email: us.medicaldevices@bsigroup.com
Phone: +1 888 429 6178




