The FDA has announced its intent to replace the Quality System #Regulation (21 CFR 820) with the specifications of international #QualityManagement standard (ISO 13485:2016). What does this mean, and how can you prepare? https://t.co/AbqgROqMXv #medtech #healthcare #healthtech
Lean Entries founder @PitkanenHeikki is moderating the regulatory session at the Upgraded Life Festival #ULFFI @UpgradedFi on May 31. Come prepared with some heavy questions on the #MDR & #IVDR and other global regulations!
"We have been using Lean Entries’ service for about six months. The platform helped us to assess and cross check the classification of various medical devices. It was a useful source to support our daily business and saved us time and – as a result – money."
#DYK that there are 27K #medtech companies in Europe and almost 95% of them make up #SMEs? Find out more in @medtecheurope latest Facts & Figures brochure https://t.co/PSRkx9Mefp and during the #MedTech from 4-8 June.