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
- #IVDR and #MDR implementation seminar on 18 May at @axonlawyers #medicaldevices #ivds medicaldeviceslegal.com/2018/04/12/ivd… https://t.co/3q4PQNRr2d 3 months ago
- #MDR & #IVDR update after the first MDCG/stakeholders meeting and an IVD seminar at Axon Lawyers #medicaldevices… twitter.com/i/web/status/9… 3 months ago
- An EU Court #medicaldevices #software qualification case with a twist #samd #mdr #MEDDEV medicaldeviceslegal.com/2018/01/12/an-… 6 months ago
- Happy New Year - with the EU #MDR transition period going past halfway point #medicaldevices medicaldeviceslegal.com/2018/01/08/hap… https://t.co/PaXZpKHZza 6 months ago
- RT @IVDAust: @MedDevLegal Australian IVD Companies may also be affected by this... 7 months ago
- The notified body bottleneck in implementing EU #MDR and #IVDR becoming a problem for #medicaldevices manufacturers medtech.pharmaintelligence.informa.com/MT121869/Exper… 7 months ago
- RT @mr_mag_online: Advocaten @MedDevLegal @axonlawyers @twobirdsNL @HoyngRokh blij met komst medicijnautoriteit EMA naar Amsterdam https:/… 7 months ago
- Working on @AdvaMedUpdate workshop on implementation of the EU #MDR and #IVDR Vital for US #medicaldevices companies advamed.org/events/new-eu-… 7 months ago
- A tsunami of EU #MDR and #IVDR implementation and guidance coming your way #medicaldevices medicaldeviceslegal.com/2017/11/25/a-w… https://t.co/1L1drMEKxT 7 months ago
- #MDR and #IVDR workshop at @advamed on 4 Dec on gap assessment and transition… medicaldeviceslegal.com/2017/11/14/mdr… https://t.co/GQdTos0flI 8 months ago
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