Mike Pogose

@MikePogose

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

Worcester Beigetreten Temmuz 2013

7 Folgt15 Follower

Mike Pogose retweetet

Startups Magazine@TheStartupsMag·20 May

. @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 👉 bit.ly/2ScTLNX #IC ...

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Mike Pogose@MikePogose·23 Eyl

@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 - gov.uk/government/peo…

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Mike Pogose@MikePogose·23 Eyl

@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.

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Mike Pogose@MikePogose·23 Eyl

@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.

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Mike Pogose retweetet

Roshana 🦴@RoshanaMN·19 Nis

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 for the frontlines?*** Our regulatory specialist at @HardianHealth has written an update for anyone needing PPE regulatory approval Our first blog provided a free letter template, still available. This blog provides updated guidance hardianhealth.com/blog/ppecovid2

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Mike Pogose retweetet

Roshana 🦴@RoshanaMN·10 Nis

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 hardianhealth.com/blog/ppecovid

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Mike Pogose retweetet

Roshana 🦴@RoshanaMN·10 Nis

#PPE #PPEshortage

Roshana 🦴@RoshanaMN

QHT

Mike Pogose retweetet

Yann LeCun@ylecun·20 Oca

On the obstacles to deploying AI in radiology. Authors' prediction: "The future of diagnostic radiology is remote AI-augmented reporting…" hardianhealth.com/blog/rsna19 hardianhealth.com/blog/rsna19

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Entdecken

@Vinehealth_ @faisalislam @piersmorgan @GaryLineker @RCSnews @TheBMA @ShaunLintern @RoyLilley