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Design and Development of Software under 13485:2016 or 62304?

JoshuaFroud

Involved In Discussions
#1
Good Morning

I'm currently working through our transition materials/gap analysis for ISO 13485:2016. I'm looking at the design and development requirements and I'm a little lost. Previously I have only worked with physical goods, whereas now I work for a company produces both a physical device and the software to run it. So have little experience in the area of software.

We currently have in place a Software development Procedure based on IEC 62304 and a Design and Development procedure based in ISO 13485:2003/2012.

My question is does our software development procedure/process need to meet the requirements of 13485 in addition to 62304. I.e. at present our software development procedure makes no reference to Design Review.

Thanks in advance!
 
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Marcelo

Inactive Registered Visitor
#2
My question is does our software development procedure/process need to meet the requirements of 13485 in addition to 62304. I.e. at present our software development procedure makes no reference to Design Review.
Yes. Basically, you have to map the design controls of ISO 13485 to your software development lifecycle model (in the same way you have to map the requirements of IEC 62304 to your software development lifecycle model).
 

yodon

Staff member
Super Moderator
#3
Marcelo is correct, as usual.

The design reviews in 13485 are typically laid out as "stage gate" type reviews; i.e., we're at a particular point in the process and we do a review to make sure we're where we think we need to be and that the design is progressing correctly.

In 62304, the reviews are more "artifact oriented." For example, the step to "verify software architecture" is a (design) review of the architecture.

Because software is more evolutionary than other aspects of the design (i.e., it's easier to change the software than to re-design a board), the "stage gate" approach isn't all that effective with software - especially in a more agile environment. However, as your 13485-based design reviews occur, you should be including a review of the relevant software aspects to ensure things are tracking as planned.
 

JoshuaFroud

Involved In Discussions
#4
Thank you both for your comments. That was how I was reading the requirements, I doubted myself as the previous Quality person had only written the Software procedure to comply with 62304 and they, (in years at least), had significantly more experience than me.



Looks like I have a procedure to re-write this week!
 
#5
Hello,
I am currently working in AI-driven software for Ophthalmology and in process of implementation of ISO 13485:2016. According to the above conversation, I will have to consider ISO 13485 & IEC 62304 standards while preparing the procedure and other design related documents.
So, can I consider the same documents as a part of Medical device file (Clause 4.2.3 of ISO 13485:2016) and also preparing the design documents as per IEC 62304 would fulfill the requirements of Design and development clause of ISO 13485?

Also, for getting ISO 13485 certification do I have to define the class of the medical device? I assume that the classification differs as per country's regulations and thus it is not required now as we are not applying for any market registration. However, I have to consider the safety classification of the software as per IEC 62304.

Please advise.

Thank you
 

yodon

Staff member
Super Moderator
#6
Just to reset the baseline a bit, standards are always voluntary. They are, however, the most direct path to market clearance. Complying with a harmonized standard (like 13485 and 62304) gives you a presumption of conformity in the EU (and similarly 62304 is a recognized consensus standard in the US). So it's probably in your best interest to follow these.

Do note that both 13485 and 62304 reference ISO 14971 for overall risk management and risk is getting a lot of attention.

Oh, and usability is also getting considerable attention. Compliance to IEC 62366 is recommended.

In at least the US and EU, you do have to establish the device class. There are decision trees to help guide. 62304 requires that you define the software safety class. Especially for a "Software as a Medical Device" (SaMD), the device class and software safety class will probably parallel (i.e., if your software device class is III, you'll likely have a software safety class of C). If you have plans to obtain market clearance in the future, you'd be well advised to do all the design and development work at the level indicated by the software safety class. It's very difficult to retrospectively develop the required artifacts.

Following 62304 gets you pretty close to 13485 7.3 but there are some differences. For example, 62304 doesn't really address design verification and validation in the same manner. (And 62366 can certainly fill in some gaps here). Another difference is in planning. 13485 requires you establish the competence of personnel required. So look closely at the requirements and see what maps and where the gaps are.

A few more notes.

Every jurisdiction now is very concerned about cybersecurity. Look to see what country expectations are early. Some of the requirements drive design decisions so you'll want to build this in; it cannot be bolted on after the design is done. I know that UL has some standards (which are recognized consensus standards in the US).

At least the FDA has some working papers on AI / machine learning systems. You'll probably want to get familiar with the framework outlined since it's really an emerging field in medical devices. Much of it is about how you ensure that the learning is improving and not regressing.
 
#7
Just to reset the baseline a bit, standards are always voluntary. They are, however, the most direct path to market clearance. Complying with a harmonized standard (like 13485 and 62304) gives you a presumption of conformity in the EU (and similarly 62304 is a recognized consensus standard in the US). So it's probably in your best interest to follow these.

Do note that both 13485 and 62304 reference ISO 14971 for overall risk management and risk is getting a lot of attention.

Oh, and usability is also getting considerable attention. Compliance to IEC 62366 is recommended.

In at least the US and EU, you do have to establish the device class. There are decision trees to help guide. 62304 requires that you define the software safety class. Especially for a "Software as a Medical Device" (SaMD), the device class and software safety class will probably parallel (i.e., if your software device class is III, you'll likely have a software safety class of C). If you have plans to obtain market clearance in the future, you'd be well advised to do all the design and development work at the level indicated by the software safety class. It's very difficult to retrospectively develop the required artifacts.

Following 62304 gets you pretty close to 13485 7.3 but there are some differences. For example, 62304 doesn't really address design verification and validation in the same manner. (And 62366 can certainly fill in some gaps here). Another difference is in planning. 13485 requires you establish the competence of personnel required. So look closely at the requirements and see what maps and where the gaps are.

A few more notes.

Every jurisdiction now is very concerned about cybersecurity. Look to see what country expectations are early. Some of the requirements drive design decisions so you'll want to build this in; it cannot be bolted on after the design is done. I know that UL has some standards (which are recognized consensus standards in the US).

At least the FDA has some working papers on AI / machine learning systems. You'll probably want to get familiar with the framework outlined since it's really an emerging field in medical devices. Much of it is about how you ensure that the learning is improving and not regressing.
Thank you very much for this detailed information.
It is very informative and surely I will go through all the said requirements for QMS implementation.
Thanks again.
 
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