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
- Netherlands to adopt act on #medicaldevices hospitality and Sunshine reporting medicaldeviceslegal.com/2017/06/05/net… https://t.co/QwnWuqyJFf 2 weeks ago
- #medicaldevices #IVDs #medtech twitter.com/meddevlegal/st… 1 month ago
- RT @mstrubin: Glad to speak at #eHealthWeek on 10 May in the session "Nobody said it would be easy" on @EURO_CAS and #interoperability. @eH… 1 month ago
- Final MDR and IVDR texts published medicaldeviceslegal.com/2017/05/05/fin… https://t.co/BV73UcRto5 1 month ago
- Check out our session on #medicaldevices and #dataprotection compliance in global big data at 11:00 today at #GMTCC gmtcc.com/programme-2017 1 month ago
- New EU #medicaldevices and #IVD regulations to be published this Friday medicaldeviceslegal.com/2017/05/03/mdr… https://t.co/y0jK0x4jqi 1 month ago
- RT @EU_Growth: New rules for #MedicalDevices🌡️ adopted by @Europarl_EN for better patient protection and greater transparency: https://t.co… 2 months ago
- EU SCHEER scientific advice on breast implants published, consultation until 7 May #medicaldevices #breastimplants ec.europa.eu/newsroom/sante… 2 months ago
- EU Parliament vote final stage of adoption of new EU rules for #medicaldevices and #IVDs medicaldeviceslegal.com/2017/04/06/mdr… https://t.co/m6iiV5YrLW 2 months ago
- This is it: EU #MDR & #IVDR texts final and ready for voting #medicaldevices #ivds medicaldeviceslegal.com/2017/03/05/thi… https://t.co/Kc0gOTVKau 3 months ago
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Recent comments

Julie O. on Final MDR and IVDR texts …
Erik Vollebregt on Product liability for devices…
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