The conformity assessment of AI-based medical devices (“AIMD”) raises questions for companies developing and marketing such devices. This is true ...

STOCKHOLM, Sweden--(BUSINESS WIRE)--atsec is thrilled to announce it is the first accredited conformity assessment body (CAB) for the new EU Common Criteria (EUCC) certification scheme. With this ...

Many facets of our daily lives depend on standards. Standards influence the products we use, the foods we eat, how we communicate, our means of travel, our modes of work and play, and many other ...

One unintended reaction to the flooding of the world’s information conduits with fake images and synthetic people is that ...

*This article was updated to specify the scope of the conformity assessment procedure. The EU lawmakers leading on the AI Act have circulated revised compromise amendments on how AI systems that could ...

Conformity assessment refers to any activity designed to confirm that a product or service meets requirements contained in a specification (typically a standard). A specification is the technical ...

The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program is one of a number of efforts on the agency’s part to reduce the drag on premarket medical device submissions, but the ...

Having attended numerous conferences hosted by different industry groups over the past few years, I have found that the conversations are frequently muddled, lacking structure, and without a generally ...

The number of regulatory frameworks that involve assessments of AI systems for various reasons has exploded in a short time and yet there is little consensus on questions like why, when, how and for ...