Artificial Intelligence

To master the requirements of AI regulation

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Dedicated experts, a customized solution

Medical devices incorporating software with AI have made a remarkable breakthrough in recent years.
These medical devices are within the scope of the MDR / IVDR.
Medical devices software with AI algorithms that contribute to patient safety are within the scope of the AI ACT.

MD101 can help you comply with both Medical Device and AI regulations:

  • Support in setting up an ISO 42001-compliant QMS.
  • Assistance in compiling the technical documentation required by the AI Act.
  • Support in carrying out risk analyses combining the objectives of medical device regulations (safety and performance) and AI (ethics, responsible use).
  • Audit according to the joint requirements of ISO 42001, RIA, ISO 13485 and RDM / RDIV.

MD101, co-founder of the .emt Alliance

United to support companies in HealthCare

MD101, co-founder of the .emt Alliance

MD101, founding member of The MedTechAlliance, USA

Catalyzing global growth and innovation

MD101, founding member of The MedTechAlliance, USA