Standards | medicaldeviceslegal

Category: Standards

Team NB FAQ on EN62304 standard for software lifecycle processes

CE marking of apps: It Can Be Done and Here Is How

Regulating Medical Software and nothing new on the Recast

Standardisation, anyone?

ISO 14155:2011 is here: revised standards for medical devices clinical trials

New standard for medical technology used at home

Software design for medical devices

Erik Vollebregt

Erik is a founding partner of the boutique life sciences law firm Axon Lawyers and specialised in EU legal and regulatory issues relating to medical technology
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Medicaldeviceslegal tweets
- Qserve / Axon EU #MDR and #IVDR pop-up conference in Boston MA on 18 July #medicaldevices #invitrodiagnostics #IVDs… twitter.com/i/web/status/1… 2 weeks ago
- 'Person responsible for regulatory compliance" #PRRC guidance under EU #MDR and #IVDR published #medicaldevices… twitter.com/i/web/status/1… 3 weeks ago
- Bottleneck of bottlenecks for #notifiedbody capacity under EU #medicaldevices law #mdr #ivdr medicaldeviceslegal.com/2019/06/13/bot… https://t.co/McscK8wqPU 1 month ago
- National MDR and IVDR implementation news - Netherlands implementation decree consultation #MDR #IVDR #nationallaw… twitter.com/i/web/status/1… 2 months ago
- IVDR, in-house developed tests and the state of MDR/IVDR implementation medicaldeviceslegal.com/2019/05/12/ivd… https://t.co/E4x5ZJGzYf 2 months ago
- This was not the Corrigendum you were looking for, more #MDCG guidance on #scrutiny and national #Brexit exemption… twitter.com/i/web/status/1… 3 months ago
- What to expect for 2019 with EU #MDR and #IVDR implementation? #medicaldevices #ivds #medtech #invitrodiagnostics… twitter.com/i/web/status/1… 4 months ago
- Don't give me #Brexit problems, give me Brexit scenarios #medicaldevices #IVDs #medtech #CEcertificates #CEmarking… twitter.com/i/web/status/1… 4 months ago
- First notified body for EU MDR designated! #MDR #IVDR #medtech #medicaldevices medicaldeviceslegal.com/2019/01/21/fir… https://t.co/X46AeuHftM 6 months ago
- The implementation of the new EU #MDR and # IVDR in 2019: up or out, sink or swim #medicaldevices #ivds #medtech… twitter.com/i/web/status/1… 6 months ago
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