Friday 4 November 2016
By Mitch on Friday 4 November 2016, 15:37 - Misc
The FDA released a guidance on clinical evaluation of standalone software medical device (a.k.a SAMD) in October 2016. This guidance is the same text and has the same presentation as the International Medical Device Regulatory Forum (IMDRF) guidance on SAMD clinical evaluation published in August 2016.
Tuesday 1 November 2016
By Mitch on Tuesday 1 November 2016, 21:09 - Standards
IEC 82304-1:2016, the missing link on standalone medical device software validation has been published!
See the official version on IEC webstore, and comments made on the FDIS (the final version shouldn't have changed).
Now we wait for the FDA to recognize it and the EU to harmonize it!
Monday 24 October 2016
By Mitch on Monday 24 October 2016, 16:50 - Regulations
We begin today a series of posts on cybersecurity in medical devices. Cybersecurity was not a subject before the advent of computerized medical devices. Now that every manufacturer wants its connected medical device, cybersecurity matters!
Let's start with the regulations.
Friday 2 September 2016
By Mitch on Friday 2 September 2016, 13:27 - Regulations
We've seen in the previous article the revolution in the regulatory classification brought by the new rule 10a for standalone software.
Let's see now the other changes. These changes are relevant for all software: standalone, embedded, device or accessory.
They're not as big as the new rule 10a, but they will deserve a significant amount of man-hours and documentation.
Friday 19 August 2016
By Mitch on Friday 19 August 2016, 13:48 - Regulations
The FDA released three new FDA guidances in July 2016:
- Two draft guidances on Deciding When to Submit a 510(k) for a Change to an Existing Device,
- The final guidance on General Wellness: Policy for Low Risk Devices.
Wednesday 10 August 2016
By Mitch on Wednesday 10 August 2016, 10:09 - Regulations
A new version of the MEDDEV 2.1/6 was published in July 2016.
The first version of 2012 was a major breakthrough. The new version won't change you life. Almost nothing new, excepted a few definitions on software, input data, output data, a remarkable reference to IMDRF definitions, and a non-significant update of the first decision tree.
Add to that a few typos, and you have the new version of the MEDDEV:
- "lossless compression" disappeared from the decision tree (was it intentional?) but is still present in the explanations of decision step 3,
- Decision step 7 doesn't have any explanation.
MEDDEV for nothing ♫ and tips for free ♬.
Friday 22 July 2016
By Mitch on Friday 22 July 2016, 13:28 - Regulations
The final version of the negotiated text of the new Medical Device Regulation (MDR) was published by the European Commission in June 2016. It is a big upheaval for all medical device manufacturers. Contrary to what the draft version of September 2015 contained, software is invited to the party.
Friday 1 July 2016
By Mitch on Friday 1 July 2016, 13:22 - Processes
Following the discussion on ISO/TR 80002-2 and AAMI TRI 36 in the previous article, here are some tips on how to validate workflow and data management software like Jira or Redmine.
Friday 10 June 2016
By Mitch on Friday 10 June 2016, 13:56 - Standards
ISO/TR 80002-2 is the future technical report on the validation of software used in regulated processed. The last version of this document, a Draft Technical Report (ISO/DTR 80002-2:2016), was released to the members of the standard committee for comments in May 2016.
This document is still a draft and is to be released by the end of 2016 or early 2017. There are high expectations on this document, since the introduction of requirements on validation of software used in the QMS in section 4.1.6 of ISO 13485:2016.
Friday 6 May 2016
By Mitch on Friday 6 May 2016, 13:33 - Standards
Almost four years since I wrote in 2012 the post Is my software in class A, B or C?.
In 2015, IEC 62304 Amendment 1 was published, changing a bit the game about software safety class.
Friday 8 April 2016
By Mitch on Friday 8 April 2016, 14:25 - Standards
Continuing our series about IEC 82304-1, let's see the consequences of this standard on agile software development processes.
Friday 11 March 2016
By Mitch on Friday 11 March 2016, 14:53 - Standards
We had in a previous article an overview of IEC 82304-1 Health software -- Part 1: General requirements for product safety, its scope and its relationships with other standards like IEC 62304.
This article presents more in details (but not too much, we're not going to rephrase the standard) the requirements of IEC 82304-1.
Wednesday 17 February 2016
By Mitch on Wednesday 17 February 2016, 10:13 - Regulations
Warning: obsolete content. Please read: Is my software in class I, IIa, IIb or III.
Last update on 2016/07/31.
The British Standard Institute published in February 2016 a white paper titled How to prepare for and implement the upcoming MDR – Dos and don’ts. Register on BSI website to download the paper.
This white paper gives top-notch recommendations on the way to compliance with the future EU Medical Device Regulation (MDR), based on the draft version. But their interpretation of MDR classification rules on standalone software are somewhat surprising.
Friday 5 February 2016
By Mitch on Friday 5 February 2016, 13:45 - Regulations
Friday 29 January 2016
By Mitch on Friday 29 January 2016, 14:30 - Regulations
The FDA released one week ago a new draft guidance on Postmarket Management of Cybersecurity in Medical Devices.
This guidance is the sister of the guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices released in 2014. Both guidances address cybersecurity at different steps of software lifecycle: the 2014 guidance is about cybersecurity during design and development, the 2016 draft guidance is about cybersecurity during post-market surveillance.
Friday 15 January 2016
By Mitch on Friday 15 January 2016, 14:30 - Standards
IEC 82304-1 Health software -- Part 1: General requirements for product safety standard is still under development. Its status is visible on the page of ISO website, dedicated to IEC 82304-1. There is even a preview of the first three pages of this draft standard.
Friday 1 January 2016
By Mitch on Friday 1 January 2016, 15:37
Happy New Year 2016 to all of you, readers of this blog!
You are now more than 200 unique visitors per day.
Many thanks to all of you.
Friday 18 December 2015
By Mitch on Friday 18 December 2015, 15:33 - Misc
The IMDRF published in October 2015 the guidance document titled "Software as a Medical Device (SaMD): Application of Quality Management System" in its final version.
Saturday 7 November 2015
By Mitch on Saturday 7 November 2015, 10:33 - Misc
George Boole was born the November 2nd 1815.
The November 2nd 2015 was its bicentenary. He's one of the few scientists whose name became an adjective: boolean.
Happy Birthday Professor Boole!
Thursday 29 October 2015
By Mitch on Thursday 29 October 2015, 17:10 - Misc
The page on essential list of guidances for CE Mark and FDA clearance of software medical devices has been updated.
It contains links to the most recent version of EU and FDA guidances as well as new FDA guidances about mobile apps and cybersecurity.