Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FAQ 62304: EU device software experts look to early 2013 for public release of document

This article was originally published in SRA

Executive Summary

The EU expert team co-ordinating the drafting of the FAQ document arising from questions invited from interested parties who use EN 62304, the harmonised European version of the international standard IEC 62304 (medical device software – software life-cycle processes), expects to release the document, FAQ 62304, to the public in early 20131-3.

You may also be interested in...



‘Ready For Day 1’ – UK MHRA’s Statement Of Intent For Post-Brexit Medtech Regulatory System

The MHRA has been working all hours to ensure the standalone medtech UKCA mark works operationally and procedurally in the UK as of 1 January 2021.

APACMed 2020: Healthineers Evolves Therapy Remit And Makes All Asia An Equal Priority

Siemens Healthineers' product mix of diagnostics and imaging products meant it was in the middle of a very dynamic situation when COVID-19 struck.

Post-Brexit MHRA Will Embrace Medtech ‘Innovation Pull’ In The UK

The national regulator is to undergo a review in 2021 as the UK begins life as a former EU member, presenting opportunities to be seized.

UsernamePublicRestriction

Register

LL010986

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel