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Alabama Small Business Development Center Network

CE Marking in Europe – Medical Device Regulations and AI [10/1/2024 12:00]

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.

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