What is the event about?
At BSI, we fully understand the difficulties that may be encountered throughout the process of placing an in vitro diagnostic device on the market. From application to conformity assessment, through certification and post-market surveillance.
Our Meet the Experts event gives you the opportunity to hear from BSI’s world-renowned experts about regulatory and compliance expectations for CE mark certification and explore a client’s journey to certification. Throughout the day, our experts will provide insights and guidance on the process to place an in vitro diagnostic device on the market, clarification on specific requirements, QMS, AI in medical devices and more.
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.
As your independent market-leading experts in patient safety, we enable effective market access for medical technologies.
Agenda
| Time | Topic |
| 8:00 am - 9:00 am | Continental breakfast |
| 9:00 am - 9:10 am | Welcome & Introductions |
| 9:10 am - 9:50 am | QMS under IVDR, including MDSAP |
| 9:50 am - 10:30 am | IVD Regulatory Update |
| 10:30 am - 10:45 am | Break |
| 10:45 am - 11:45 am | Client Journey to Certification: a real-world example and lessons learned from IVDR submissions |
| 11:45 am - 12:15 pm | AI Update |
| 12:15 pm - 1:15 pm | Lunch |
| 1:15 pm - 2:15 pm | Navigating IVDR – technical content Common pitfalls and the journey to success |
| 2:15 pm - 3:00 pm | Companion Diagnostics update |
| 3:00 pm - 3:15 pm | Break |
| 3:15 pm - 3:50 pm | Meet the Experts Panel Q&A |
| 3:50 pm - 4:00 pm | Closing |
What will participants gain?
- An understanding of the IVDR current state of play
- QMS under IVDR, including MDSAP
- Understand more about the journey to certification with BSI
- The latest insights on AI for Medical Devices
- The opportunity to engage with BSI experts and industry peers
Who should attend?
This event has been created for in vitro diagnostic device manufacturers, regulatory professionals and consultants in the medical device industry who are navigating QMS and IVDR regulations to bring products to market.
To find out more about our comprehensive and proven regulatory services, visit our dedicated Medical Devices webpage.
Email: us.medicaldevices@bsigroup.com
Phone: +1 888 429 6178
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