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
Email Subscription

Enter your email address to subscribe to this blog and receive notifications of new posts by email.

Join 5,836 other followers
Subscribe via RSS

RSS - Posts
RSS - Comments
All content on this blog is subject to a Creative Commons Licence
Medicaldeviceslegal tweets
- Welcome to 2020 - year of the proof of the MDR pudding #medicaldevices #MDR #medtech medicaldeviceslegal.com/2020/01/13/wel… https://t.co/lLMM4h8CMt 1 week ago
- A not so happy #MDR and #IVDR Christmas Carol #medtech #eumdr #medicaldevices medicaldeviceslegal.com/2019/12/25/a-n… https://t.co/GNyRDJ5TcF 1 month ago
- More on the #PRRC under new EU #medicaldevices regulations #MDR #IVDR medicaldeviceslegal.com/2019/12/12/mor… 1 month ago
- The Commission and the Council on the #MDR state of affairs #medicaldevices #medtech #eumdr medicaldeviceslegal.com/2019/12/10/the… https://t.co/coF7fV5s3Y 1 month ago
- #Corrigendum 2 to the EU #MDR and the (potential) consequences for class I #medicaldevices #medtech… twitter.com/i/web/status/1… 1 month ago
- #Eudamed delayed, but #MDR not delayed - now what? #medicaldevices #medtech #IVDR medicaldeviceslegal.com/2019/11/19/eud… https://t.co/kZQblUstOU 1 month ago
- Counting down to the #MDR date of application, and the legal stuff to get right before end May 2020 #medicaldevices… twitter.com/i/web/status/1… 2 months ago
- New sort of applicable economic operators regulation for medical devices in the EU: the Market Surveillance Regulat… twitter.com/i/web/status/1… 5 months ago
- € 500 per data subject in immaterial damages - a quantification of why #GDPR matters #dataprotection #cybersecurity… twitter.com/i/web/status/1… 6 months ago
- Qserve / Axon EU #MDR and #IVDR pop-up conference in Boston MA on 18 July #medicaldevices #invitrodiagnostics #IVDs… twitter.com/i/web/status/1… 6 months ago
Most used tags on this blog

3D printing advertising apps authorised representative borderline Brexit BSi business compliance CE marking Clinical evaluation Clinical investigation clinical trials COCIR competition law conferences Council Cybersecurity Dalli data protection DIA Euromeeting e-labeling eHealth EN 14155 enforcement ENVI Eucomed Eudamed FCPA FDA GDPR genetic testing GHTF HCP hospitals in vitro diagnostics ivd IVDR ivds labeling Liese M&A market surveillance MDD MDR MEDDEV medicinal products mhealth mobile medical apps notified bodies notified body patents personal data PMA PMS post marketing surveillance product liability quality system Recast reprocessing revision Roth-Behrendt scrutiny Security seminar software standalone software standards subcontractors telemedicine transition plan transparency trilogue UDI Unannounced audits vigilance
Recent comments

Julie Omohundro on Welcome to 2020 – year o…
Julie Omohundro on Welcome to 2020 – year o…
Oliver Bisazza (MedT… on Welcome to 2020 – year o…
Most used categories on this blog

Accessories Advertising Borderline Brexit Business compliance CE marking Clinical evaluation Clinical investigation Data Protection e-commerce eHealth Eudamed FCPA In Vitro Diagnostics IVDR Labeling M&A MDR mHealth Notified Body Personal data Placing on the market PMS Product liability Quality system Recast Software Standards Uncategorized Vigilance
Archives
Archives