Mike Pogose

Consulting in Innovation Management - Project and Quality Assurance - Medical Device

[Startups Magazine @TheStartupsMag]

. @Vinehealth_ has received a Class 1 Medical Device CE mark for its mobile application & VinehealthPRO web application. VinehealthPRO is used to support clinical decision making & inform development of cancer therapeutics within clinical trials 👉 https://t.co/ljhsIZgdQv #IC ...

[Mike Pogose @MikePogose]

@Meddev_guy It’s a pattern we find with academics - first time I’ve seen it in the legislature, but not surprised. I don’t know Lord Freybeg’s relevant professional experience not Lord Bethell’s is more apparent - https://t.co/w2CZEMuYHM

[Mike Pogose @MikePogose]

@Meddev_guy UK SI 2019-745 + 2019-1385 appear to replace the MDD-oriented UK 2002 medical device regulation with equivalent clauses from the MDR + IVDR.

[Mike Pogose @MikePogose]

@Meddev_guy What would be wrong with adopting the definition in the EU MDR (and the complementary in-vitro definition in the IVDR) and then following MDCG 2019-11, which already classifies software by intended purpose, not by enabling technology such as AI/ML.

[Roshana 🦴 @RoshanaMN]

Free regulatory advice for community projects making simple #PPE for the front lines

@faisalislam @piersmorgan @GaryLineker @RCSnews @TheBMA @ShaunLintern @RoyLilley @doctor_oxford @amateuradam

[Roshana 🦴 @RoshanaMN]

Making PPE?

At @HelpThemHelpUs_ we have been exploring novel ways to supply Personal Protective Equipment

So our team at @HardianHealth have put together this regulatory step by step guide for us, and others doing the same

https://t.co/yuwhzHKDjV

[Roshana 🦴 @RoshanaMN]

#PPE #PPEshortage

[Yann LeCun @ylecun]

On the obstacles to deploying AI in radiology.

Authors' prediction: "The future of diagnostic radiology is remote AI-augmented reporting…"

https://t.co/ZiEEDG7bPu https://t.co/ZiEEDG7bPu