Hi all!
CM-DM blog had a lifting, Enjoy the new responsive design!
Monday, 31 August 2015
New design
By Mitch on Monday, 31 August 2015, 09:55
Friday, 28 August 2015
Validation of software used in production and QMS - Part 3 Validation Protocol and Reports
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
Validation of software used in production and QMS - Part 2 Validation Master Plan
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
IEC 62304 Amendment 1 published
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.
Enjoy!
Now we need to wait for this version to be harmonized by EU and recognized by the USA.
Thursday, 9 July 2015
RIP Elsmar.com
By Mitch on Thursday, 9 July 2015, 17:24 - Misc
Edit 2016/05/30: Elsmar cove is back! See on elsmar.com
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.
Fortunately:
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
Validation of software used in production and QMS - Part 1 introduction
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
IMDRF document: Software as a Medical Device (SaMD): Application of Quality Management System
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
Updates to good old IEC 62304
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
When the FDA releases guidances in burst mode
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
ISO 13485 201X DIS2
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
IEC/FDIS 62366-1 released in November 2014 - part 2
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
IEC/FDIS 62366-1 released in November 2014
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.
Friday, 12 December 2014
NBOG’s Best Practice Guide 2014-3: all you wanted to know about reporting software design changes
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
Analysis of the FDA Cybersecurity Guidance
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
Content of DHF, DMR and DHR for medical device software - Part 3 DHR
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
Content of DHF, DMR and DHR for medical device software - Part 2 DMR
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
Content of DHF, DMR and DHR for medical device software - Part 1 DHF
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
When the next versions of IEC 62304 and IEC 62366 will be released?
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.
Friday, 8 August 2014
Next version of ISO 13485 postponed to 2016
By Mitch on Friday, 8 August 2014, 14:03 - Standards
Thanks to elsmar cove website, we know that the publication of the next version of ISO 13485 is postponed to 2016.
EDIT: elsmar cove forums is dead, see RIP elsmar cove.
Bye bye ISO 13485:2015,
Welcome ISO 13485:2016!
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