Regulatory Open Forum

Dear all Last night the trilogue arrives to a consensus for the Artificial Intelligence Act Do you know how the new ...

Hello Anon If it's still the same company, then the UDI can generally stay the same. You'll need to get the name and/or address ...

Hello Tim If they have asked you to label the device with their name and not yours, to maintain confidentiality, then they should ...

Hello Shikha In the US, probably not. See the guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Device". ...

Hi Terry The Australian sunscreen standard 2604 contains top-level requirements and points to several ISO standards for testing ...

This is the standard way to do accelerated aging. I'm ignoring package integrity and focusing on functionality. I'm also assuming ...

Yes: restriction of the target population would actually not be a significant change, see MDCG 2020-3 Rev 1 section 4.3.2.2, last ...

Hi Anon, I can only comment on my own experience. When I talk to other independent consultants I often hear quite different ...

Hello, Can someone advise the requirements for SPF testing of a sunscreen What tests are needed for SPF claim - Is it ISO 24444 ...

My firm regularly acts as the U.S. Agent for our international clients, so we have lots of experience with that. In general, ...