Wednesday 23 September 2015
By Mitch on Wednesday 23 September 2015, 09:57 - Standards
Long time no see. For those of you guys who have been following this blog for a long time.
Today I have time to write a short article on the new version of IEC 62366 standard: IEC 62366-1:2105 Application of usability engineering to medical devices.
Monday 31 August 2015
By Mitch on Monday 31 August 2015, 09:55
CM-DM blog had a lifting, Enjoy the new responsive design!
Friday 28 August 2015
By Mitch on Friday 28 August 2015, 12:54 - Regulations
We continue this series on validation of software used in production and QMS with the Validation Protocol and Reports.
Friday 24 July 2015
By Mitch on Friday 24 July 2015, 11:57 - Regulations
We continue this series on validation of software used in production and QMS with the Validation Master Plan (VMP).
Better than endless explanations, I added a Validation Master Plan template to my templates repository page.
Friday 10 July 2015
By Mitch on Friday 10 July 2015, 11:52 - Standards
The new version of IEC 62304, also known as IEC 62304:2015 or amendment 1 of IEC 62304 was published by the IEC at the end of June 2015.
There were no major changes compared to the drafts that were circulated earlier this year.
The two major new requirements, compared to IEC 62304:2006 are:
- Requirements about legacy software,
- Changes in the definition of the security classes, based on risk assessment.
IEC 62304:2015 is available on IEC website at the astounding / amazing / appealing / astonishing (delete as appropriate) price of 650 swiss francs (approx. US$700) for the consolidated version.
Now we need to wait for this version to be harmonized by EU and recognized by the USA.
Thursday 9 July 2015
By Mitch on Thursday 9 July 2015, 17:24 - Misc
RIP Elsmar Cove Forum.
The forums of people helping people died on June 30th 2015.
It's a great loss for quality assurance and regulatory affairs communities of medical devices, automotive, and many other industries.
More info on reddit.
Marcelo Anthunes, one of the most active moderators of Elsmar Cove, has taken upon himself to create a new Medical Devices Expert Forum. I encourage you to follow the link to this forum, sign-up, and bring your our contribution to this new initiative.
Friday 19 June 2015
By Mitch on Friday 19 June 2015, 12:34 - Processes
Validation of software is an unlimited source of topics!
After discussing in a previous article the validation of software in development process, let's see how to validate software used in production processes and in the management of QMS documents and records.
Friday 15 May 2015
By Mitch on Friday 15 May 2015, 15:34 - Regulations
The International Medical Device Regulators Forum opened a consultation on a draft document about the application of Quality Management System for Software as a Medical Device (SaMD).
The consultation was opened in march and will be closed the 1st of June.
Friday 24 April 2015
By Mitch on Friday 24 April 2015, 15:48 - Standards
Georg Heidenreich, one of the author of the Frequently Asked Questions on IEC 62304 published on the Team NB website, posted two weeks ago an article about the upcoming updates in the first amendment of IEC 62304.
Friday 20 March 2015
By Mitch on Friday 20 March 2015, 17:03 - Regulations
If you watch from time to time the new guidances released by the FDA, you probably noticed that two guidances about software were released in january and february 2015.
Wednesday 4 March 2015
By Mitch on Wednesday 4 March 2015, 16:17 - Standards
The DIS2 (2nd draft version) of the next ISO 13485 was released in february.
It is published for comments on BSI draft review system website. Go to this website and search for 13485 to have a look at this draft.
Friday 30 January 2015
By Mitch on Friday 30 January 2015, 16:44 - Standards
To continue with the last article about FDIS IEC 62366-1 standard, let's see now the consequences of this standard on software design.
Friday 9 January 2015
By Mitch on Friday 9 January 2015, 14:16 - Standards
The FDIS (final draft version) of IEC 62366-1 was released in November 2014. This version, also known as IEC 62366 2nd edition, is on the right track to be officially released in Q1 2015. It will supersede the IEC 62366:2007 + Amendment 1:2014.
By Mitch on Friday 9 January 2015, 14:00 - Misc
Happy New Year 2015!!!
Friday 12 December 2014
By Mitch on Friday 12 December 2014, 21:42 - Regulations
When should a manufacturer report devices changes or QMS changes to notified bodies, according to the 93/42/CE directive?
There hasn't been clear criteria, until the Notified Bodies Operating Group (NBOG) published the Best Practice Guide 2014-3 : Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.
Friday 21 November 2014
By Mitch on Friday 21 November 2014, 12:46 - Regulations
At last! The FDA has published last October a guidance about cybersecurity that matters!
Not that the guidance previously published about Off-the-shelf software cybersecurity wasn’t worth reading it (Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software), but its scope was more than reduced.
Friday 31 October 2014
By Mitch on Friday 31 October 2014, 12:48 - Regulations
We continue this series about DHF, DMR and DHR, with the Device History Record.
Friday 17 October 2014
By Mitch on Friday 17 October 2014, 12:44 - Regulations
We continue this series about DHF, DMR and DHR, with the Device Master Record.
Friday 3 October 2014
By Mitch on Friday 3 October 2014, 13:58 - Regulations
After a temporary absence, I'm back on the waves with a new series of articles to talk about the files required by the 21 CFR 820 regulations:
- DHF: Design History File,
- DMR: Device Master Record,
- DHR: Device History Record.
Let's begin with the DHF.
Friday 22 August 2014
By Mitch on Friday 22 August 2014, 14:12 - Standards
Continuing with the schedule of the ISO TC 210 committee, let's see when the next versions of IEC 62304 and IEC 62366 will be released.