Friday, 26 March 2021
By Mitch on Friday, 26 March 2021, 13:38 - Misc
The definition of SOUP, and the requirements related to their lifecycle in IEC 62304 processes, are totally independent of any technology. Making no technological assumption, that's the way the standard is thought, so that it can be applied to any health software.
Cloud-based applications and web technologies make an intensive use of SOUPs. Let's see how IEC 62304 requirements can be applied to these technologies.
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Friday, 15 May 2020
By Mitch on Friday, 15 May 2020, 14:00 - Processes
A recurring question is the confusion, or more precisely the difference between software release of IEC 62304, and design transfer of ISO 13485.
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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.
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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.
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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.
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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.
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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.
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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.
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Friday, 8 August 2014
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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Friday, 27 June 2014
By Mitch on Friday, 27 June 2014, 11:10 - Standards
Continuing with ISO/DIS 13485:2014, after having made an overview of software-related changes in the last article, let's focus on the new clause #4.1.6.
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Friday, 13 June 2014
By Mitch on Friday, 13 June 2014, 10:43 - Standards
ISO/DIS 13485:2014 is the draft of the next version of ISO 13485. The final version should be published in 2015.
This new version brings a lot of new requirements for management of software related to medical devices. Let's see what's inside this draft!
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Friday, 31 January 2014
By Mitch on Friday, 31 January 2014, 12:43 - Misc
Back to my blog after a while (you missed me :-)). After the previous article about usability, we're going to see the deployment of mobile medical apps. This article is the last of this series on clearance of mobile medical applications, before conclusion.
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Friday, 11 May 2012
By Mitch on Friday, 11 May 2012, 19:23 - Standards
Reading the ISO 13485 standard doesn't helped me knowing how to manage the lifecycle of software medical devices. The QMS of a software company has to be adapted to be in conformity with ISO 13485.
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Friday, 9 March 2012
By Mitch on Friday, 9 March 2012, 13:45 - Standards
Don't worry, I'm not going to talk about money and quantitative easing! I let people with better knowledge in economics (that makes a lot of people!) do that.
When I talk about inflation, I mean the inflation of software medical devices in their number and variety, which creates a collateral inflation in the number of regulations, guidances, standards, and the like.
This post is the first of a series of three. In this first post, I focus on the inflation of standards. The next one will be on the inflation of regulations and the last one on the inflation of medical devices.
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Friday, 18 November 2011
By Mitch on Friday, 18 November 2011, 18:10 - Standards
The homologation of a medical device is a complex task and can become a nightmare with devices with a high level of risk. It involves many standards and regulations, different from one country to another: FDA in the USA, CE Mark in Europe, CMDCAS in Canada, KFDA in South Korea, and so on …
Fortunately, most of these regulations have common requirements and rely on ISO standards, the most important standards being ISO 13485 and ISO 14971. If you meet the requirements of these standards, you increase your chances of passing the homologations for the devices with low risk. For devices with high risk, these standards are (almost) mandatory.
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Tuesday, 1 November 2011
By Mitch on Tuesday, 1 November 2011, 23:00 - Standards
Here is a short description of ISO and IEC standards related to software and medical devices.
The starting point is legal. Government agencies give the authorizations to manufacturers to sell their devices. These agencies rely on standards to ensure that the device was designed and manufactured in a good and safe way. Given these regulations, medical device manufacturers have to adhere to these standards. Full stop.
Let's see what these standards are.
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