Medical Device Archives

Breakthrough Device Designation: I’ve Received the Designation, Now What?

Apr 3, 2023 | White Paper

Being in unchartered territory within a regulated space can be scary! Yet, it is in unchartered territory that new breakthrough technologies and treatments are found. The FDA Breakthrough Devices Program can alleviate some of the worry. The FDA is committed to a high...

‘Scorecard’ By Notified Body BSI Affixes Mediocre ‘Yellow’ Designation To Second Half Of E.U.’s 19-Point MDR/IVDR Compliance Plan (2 Of 2)

Nov 8, 2022 | News

When it comes to the medtech space implementing the second half of a 19-point action plan from the Medical Device Coordination Group, it’s pretty much yellow – or slow – across the board. At least that’s the assessment by notified body BSI Group. The MDCG’s plan,...

Breakthrough Device Designation: I’ve Received the Designation, Now What?

‘Scorecard’ By Notified Body BSI Affixes Mediocre ‘Yellow’ Designation To Second Half Of E.U.’s 19-Point MDR/IVDR Compliance Plan (2 Of 2)

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Breakthrough Device Designation: I’ve Received the Designation, Now What?

‘Scorecard’ By Notified Body BSI Affixes Mediocre ‘Yellow’ Designation To Second Half Of E.U.’s 19-Point MDR/IVDR Compliance Plan (2 Of 2)

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