Standards
Explanations on standards, howto's
My own experience on implementation of standards
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Friday, 5 April 2013
By Mitch on Friday, 5 April 2013, 16:50
Manufacturers of medical devices often ask themselves the obvious question:
Is it mandatory to be compliant both with IEC 60601-1 and IEC 62304?
Similarly, manufacturers of in vitro diagnosis devices ask themselves:
Are my devices in the scope of IEC 62304?
Obviously, medical devices (MD) with electric or electronic components are in the scope of IEC 60601-1. And in-vitro diagnosis devices (IVD) with electric or electronic components are in the scope of IEC 61010-1.
Do MD and IVD that embed software, fall in the scope of IEC 62304?
This is not so obvious.
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Friday, 8 March 2013
By Mitch on Friday, 8 March 2013, 14:09
We've seen in the two previous posts several solutions on how to treat legacy software according to IEC 62304.
But there is nothing equivalent to this discussion in IEC 62304. The standard is silent about these situations.
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Friday, 1 March 2013
By Mitch on Friday, 1 March 2013, 14:31
We've seen in the last post how to manage changes in legacy software. Let's see it from another point of view: the type of legacy software.
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Friday, 22 February 2013
By Mitch on Friday, 22 February 2013, 14:09
Most of medical devices manufacturers have legacy software that was not designed according to IEC 62304. The devices that embed legacy software were once verified and validated. These devices and their software work well and no major adverse event were raised by software issues.
But one day, the manufacturer decides that it's time to bring that legacy software into line with IEC 62304, to align the technical file of that software (or the contribution of software to technical file content) with up-to-date standard or regulatory requirements.
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Monday, 21 January 2013
By Mitch on Monday, 21 January 2013, 15:34
In the last two posts, we've seen what a software unit is, and when to do software detailed design, according to IEC 62304 and FDA Guidances.
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Friday, 18 January 2013
By Mitch on Friday, 18 January 2013, 15:45
In my last post, I explained what criteria should be taken to define the level of details of software units in a software design. This activity is not mandatory for all levels of risk of software in medical devices, though, according to IEC 62304.
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Friday, 11 January 2013
By Mitch on Friday, 11 January 2013, 14:08
IEC 62304 requires to split architecture of class C (mission critical) software into software items and software units. Software units are software items that can't be split into sub-items, according to the standard. Okay. But how to decide that an item can't be split into sub-items, and is a unit?
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Friday, 19 October 2012
By Mitch on Friday, 19 October 2012, 04:32
Let's continue a former post about dealing with ISO 13485 in a software company. ISO 13485 and ISO 14971 are a bit like sister standards. You can't implement one without the other!
But how to deal with ISO 14971 in a software company, actually?
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Friday, 11 May 2012
By Mitch on Friday, 11 May 2012, 19:23
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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Saturday, 14 April 2012
By Mitch on Saturday, 14 April 2012, 23:35
IEC 62304 defines three safety classes for software:
- Class A: No injury or damage to health is possible
- Class B: Non-SERIOUS INJURY is possible
- Class C: Death or SERIOUS INJURY is possible
Here comes the eternal question: Which class my software belongs to?
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Friday, 9 March 2012
By Mitch on Friday, 9 March 2012, 13:45
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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Monday, 30 January 2012
By Mitch on Monday, 30 January 2012, 03:17
This article was moved Here.
Friday, 18 November 2011
By Mitch on Friday, 18 November 2011, 18:10
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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Friday, 4 November 2011
By Mitch on Friday, 4 November 2011, 13:21
A lot of standards and regulations exist about medical devices: how to design, to produce, to sell, to monitor their use … Everything about each step in the life of devices, from the initial idea 10 years before selling anything, to the archiving of records 10 years after the last item has been sold.
A lot of specific standards or guidances on how applying medical devices standards exist about software. That’s the consequence of software being very specific (I should say peculiar), compared to other components in medical devices. Conception is the most critical part in the lifecycle of software. Software is never 100% finished, user always want enhancements and modifications.
From my own experience in the field, I gathered 5 basic recommendations you should follow.
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Tuesday, 1 November 2011
By Mitch on Tuesday, 1 November 2011, 23:00
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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