A key takeaway from the Nordic Health Resolution by #Health100 @UpgradedFi: "Startups need to be aware of the regulatory environment and actions needed, rather sooner than later." We @LeanEntries provide the solution: #Entries digital regulatory runways + training + hands-on help
A pleasure to join the Easy Medical Device podcast with Monir @elazzouzim for those with limited resources to learn on #medtech #regulations! Go listen to the podcast and follow the free trial into #Entries, the digital regulatory runways by @LeanEntries!
It's an honour to be one of the service providers within the @HealthTechN ecosystem with such great results! Our digital regulatory runways #Entries help in turning #regulatory #compliance into a strength early on for the #medtech #startups!
The draft corrigendum to #EUMDR is out. If the @europeanparliam passes this, it will mean a great relief to manufacturers with Class I #medicaldevices upgraded to higher classes, with transition period through to May 2024: https://data.consilium.europa.eu/doc/document/ST-13081-2019-INIT/en/pdf
#Entries, the digital regulatory runways provided by us @LeanEntries, now contain the MDCG 2019-11 guidance on qualification and classification of #MedicalDeviceSoftware according to the #EUMDR and #EUIVDR. And all of this in a minute format at http://www.leanentries.com, as always!
A new report reveals that the Netherlands and the Nordics continue to be seen as “role models” for the adoption and use of eHealth in Europe, based on the responses of over 500 professionals in the field. #HIMSSNordic @McKinsey https://bit.ly/36MkB2C
Here's the best current update on how the #EUMDR is building up in practice by Erik Vollebregt @Biotechlegal. A lot to consider for anyone in #medtech. https://www.linkedin.com/posts/erikvollebregt_counting-down-to-the-mdr-date-of-application-activity-6594927209826267136-qgv9