The European Commission has released a draft guidance and reporting template to support the upcoming requirements of the EU AI Act. These docum...
RAPS 2025 – What We Learned About AI, Submissions, and Where Regulatory Heads Next
We are thankful for the opportunity to engage with a large number of attendees at the RAPS Convergence — especially our clients who stopped b...
Major Changes to UK MHRA Medical Device Registration Fees
Call to Action in the UK database: Save money by deactivating devices that are no longer placed on the UK market. The UK’s Medicines and ...
Eudamed Registrations are Coming — We Can Do the Job for You!
The Eudamed actor and device registrations will become mandatory next year (May?)*. Failing to comply could jeopardize device conformity and di...
