On-Demand: CE Marking in Europe – Medical Device Regulations and AI [10/1/2024-12/31/2024]
Live webinar recorded on 10/1/2024
Please join the Alabama International Trade Center and BSI Group for a webinar:
CE Marking in Europe – the State for the Medical Device Regulations in Europe and AI
Agenda:
- The State for the Medical Device Regulations in Europe
- MDR/IVDR/CE Marking/UKCA
- QMS – ISO 13485 & Medical Device Single Audit Program (MDSAP)
- Q&A
- Artificial Intelligence (AI) EU Regulation
- What is the AI Regulation
- Review of the AI Regulation
- Q&A
BSI Group:
The British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
Speakers:
Johnathon Bis; Commercial Operations Director; Regulatory Services, Americas
Email address – Johnathon.bis@bsigroup.com
John Bis is responsible for leading the commercial operations team to support client needs while ensuring BSI’s values are upheld.
John has over 12 years of experience with BSI serving medical device manufacturers and over 30 years in the medical device / healthcare industries. He has a passion for supporting manufacturers to ensure patient safety.
Sarah Mathew: Regulatory Lead, AI Notified Body
Email address – sarah.mathew@bsigroup.com
Sarah Mathew is a regulatory lead on behalf BSI’s AI Conformity Assessment Body. She is a technical member of the European Electrotechnical Joint Technical Committee for Artificial Intelligence and NIST’s US AI Safety Institute Consortium. Prior to her current role, Sarah was a Technical Specialist and Scheme Manager with BSI’s Active Implantable Medical Device Notified Body, where she performed and led conformity assessments. Her background includes electronics engineering, power systems, and wireless communications.