Introduction of EN 62304 - Life Cycle Requirements for Medical Device Software.

A

alexander73

#1
We produce radiographic medical devices. They include both embedded software (microcontrollers) and stand-alone software (PACS). I’m involved in the process of quality assurance, we got ISO 13485 certificate 3 years ago. Now it’s time to introduce the requirements of the new standard EN 62304 Medical Device Software.

The question is that there is a difference between entire device risk management and software risk management. We used to apply the extended tables from ISO 14971 and IEC 60601-1 (potential electrical, electromagnetic, mechanical hazards). Nevertheless I can’t find out special literature on software, almost all the materials concentrate on software security. This aspect is very important but it’s just the particular one among many other. Frankly speaking I’d like to view an example of risk management file for the specific programmable device, or a sample potential risk questionnaire stressed on the software. If you can share this example it would be great. If it’s not for free we are ready to discuss the price. Finally if you give a link to the special library it would be very helpful.

The second question is the hazard software risk analysis approach. For example I studied FMEA and FTA, though I don’t know to what extent they are appropriate for software. Please point me to where “dig out”.

Thanks a lot.
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#3
Alexander

You´re right, there´s a lot of difference bewtween software and device risk management, and there´s a lot of differences betweens applying ISO 14971 to device and software. As i pointed on this thread (Medical Device Software Risk Management and ISO 14971:2007)

Oh, IEC is working in a document on guidance on applying ISO 14971 to medical device software. You can try to get it through the National Committe of your country. The document is:

IEC/TS 80002 Ed. 1.0 - Medical device software - Guidance on the application of ISO 14971 to medical device software

And it really provides a lot of guidance (the pre-approved draft is almost 80 pages long!).
I think this is the documen t you´re looking for.

EN 62304 is not a standard for software risk management, it´s a standard which provides an example of a software life cycle to be used during product development (and a life cycle processe, besides being a good design practice, is a requirement of some other standards, for example, IEC 60601).

Keep in mind that, although there´s differences, there´s still a common point - identify hazardous situations (that can come from either device or software or both) and manage the risks related to these situations.

The IEC documentsalso has some guidelines on the software risk analysis aproach.

There´s few literature on the subject, as you can see. One paper i found interesting is - Retrofitting software safety in an implantable medical device, on IEEE Software (http://ieeexplore.ieee.org/xpls/abs_all.jsp?arnumber=25120). It gives an example on how to "fit" safety in an already designed software (in fact it uses the risk management principles backwards :))


This is, in my mind, a real complicated subject, and i would love a further discussion on the topic. Feel free to contact me.
 
A

alexander73

#4
Oh, IEC is working in a document on guidance on applying ISO 14971 to medical device software. You can try to get it through the National Committe of your country. The document is:

IEC/TS 80002 Ed. 1.0 - Medical device software - Guidance on the application of ISO 14971 to medical device software

I think this is the documen t you´re looking for.
Hello! Thanks for the response.

Unfortunately I I have received the following reply from IEC:

"The IEC Central Office cannot sell or send out working documents because they are still in the project stage and modifications may overcome. Only agreed and published standards are available for sale."

Where can I get the IEC/TS 80002 Ed. 1.0 ?
 
W

wrodnigg

#6
Thanks for the hint!

I have the IEC62A_591_CD,IEC 80001 Application of risk management for IT-networks incorporating medical devices
in my standards committee for review (till end of Feb.), but no sign of 80002.


I will ask my colleague who is in the IEC mirror group to get a copy of 80002...
 
A

alexander73

#7
I am situated in Russia. Today I asked our IEC National Committe and received nothing. They said they don't have it at all and heard about this document for the first time. If you have we'are ready to purchase from you.
 
W

wrodnigg

#9
Back to 62304:

There is no strict requirement to follow this standard, because it is not harmonized yet (and there are severe discussions whether to do so or not)

From the new MDD there is the clear requirement to establish a product (development) lifecycle and to validate the software (validation is not covered by the scope of the 62304).

This standard is not bad at all (the german translation is really bad), it is a little bit narrow from the content, and you can use it as guideline...

There is a new 14971:2007 which has some minor changes in the methods for risk management.

There are also two new standards projects in ISO/TC215 WG4: ISO 29321 ISO 29322 for clinical risk management on health software (NOT medical device software).

I have just written a paper on a reference model for risk management on health software (but its german) which is similar to the model in the 14971, but slightly different...

If you are looking for literature go for "Nancy Leveson" who has written excellent publications and books in the 90s.

I am looking forward to discussions on this topic...
 

Marcelo

Inactive Registered Visitor
#10
Hello wrodnigg

Even if the standard is harmonized, you do not ve to follow it. It´s just the easiest route. But i think you know that anyway :)

Anyway, i think everyone can benefit from it´s use. IEC 60601-1-4 required a background on software engineering for the application of the development life cycle that confused a lot of people (and here in Brazil a lot of manufacturers employ software developers which do not have a full software development background :-(). So i´m hoping that this "road" to the development lifecycle provided by EN 62304 help the manufactuers implement software safety correctly (in Brazil, in fact, IEC 60601-1-4 is not used and i do not know any manufacturer which implements software safety in a structured way).

A shame your paper is in german, i would love to read that.

Cheers!
 
Thread starter Similar threads Forum Replies Date
G Question about Non-conformances during New Product Introduction Nonconformance and Corrective Action 14
S MDR & IVDR Introduction in late May 2017 EU Medical Device Regulations 1
S New Product Introduction Procedure - NPI Document Control Systems, Procedures, Forms and Templates 1
V Design Transfer to production = New product introduction ?? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
E Does introduction of a new brochure require a 510K? US Food and Drug Administration (FDA) 7
K Auditing New Product Introduction Process General Auditing Discussions 21
K NPI (New Product Introduction) Quality Plan Outsourced Manufacturer/Supplier APQP and PPAP 3
A What should be the contents of the New Gage Introduction Form ? General Measurement Device and Calibration Topics 3
T Raw Parts Inspections for NPI (New Product Introduction) Phase Supplier Quality Assurance and other Supplier Issues 1
A Food Warehouse ISO 9001 Audit and Newbie Introduction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Changes required to procedures after introduction of SAP Document Control Systems, Procedures, Forms and Templates 3
J EC Certificate and European Market Introduction CE Marking (Conformité Européene) / CB Scheme 8
AnaMariaVR2 Pharma ?Quality by Design? (QbD): An Introduction, Process Development & Applications Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
M Introduction to the Medical IT, Medical software and Health Informatics forum Medical Information Technology, Medical Software and Health Informatics 4
P Introduction of SPC to the Supply Chain Statistical Analysis Tools, Techniques and SPC 18
M NPDI (New Product Development & Introduction) Examples needed Excel .xls Spreadsheet Templates and Tools 3
S Monozukuri Rules for NPI (New product Introduction) - Help to get Lean in Manufacturing and Service Industries 3
D Introduction Coffee Break and Water Cooler Discussions 4
V Introduction Imported Legacy Blogs 6
E FDA New Product Introduction Regulations help needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M TPM Announcement Letter for TPM introduction in a organisation Lean in Manufacturing and Service Industries 3
U Introduction of SPC - Embarking on my first implementation for precision machining Statistical Analysis Tools, Techniques and SPC 11
A QMS Introduction - I have been asked to give a brief introduction of our QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B New Product Development and Introduction Manual Manufacturing and Related Processes 5
P Introduction & Latest version of AIAG Control Plan request IATF 16949 - Automotive Quality Systems Standard 3
Hershal Introduction to ANS/ISO/IEC 17025 and Z540 ISO 17025 related Discussions 2
Q Procedure for New Product Introduction (NPI) - Build to print shop Various Other Specifications, Standards, and related Requirements 6
S NPI (New Product Introduction) in Electronics Industries Document Control Systems, Procedures, Forms and Templates 10
L Introduction of Compulsory Bar Coding of Medical Devices in the US? ISO 13485:2016 - Medical Device Quality Management Systems 19
Y NPI (New Product Introduction) Process Qualification System Required Document Control Systems, Procedures, Forms and Templates 8
G Introduction to TS 16949 - Excel Partnership Course Training - Internal, External, Online and Distance Learning 4
Manix TS16949 Training Requirements - Basic introduction to the standard vs. Lead Auditor Training - Internal, External, Online and Distance Learning 8
J Free Introduction Course - VBA (Visual Basic for Application) in Excel to make forms Excel .xls Spreadsheet Templates and Tools 10
C Definition NPI (New Product Introduction) Readiness - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
B Educating Employees - Introduction to what quality is all about ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Six Sigma .ppt or .doc Presentations - Awareness session or introduction wanted Training - Internal, External, Online and Distance Learning 17
A Design document - Seeking "New Product Introduction" manual example Design and Development of Products and Processes 7
K Games for training - Introduction to ISO 9001 for Upper Management Quality Manager and Management Related Issues 9
R Where can I get ISO 13485:2003 Introduction Training Videos Training - Internal, External, Online and Distance Learning 3
G Introduction of ISO/IEC17024:2003 in Australia General Auditing Discussions 3
D ISO 9001 Introduction and Training for Employees Training - Internal, External, Online and Distance Learning 36
D Fresh Coffee - An Introduction Coffee Break and Water Cooler Discussions 65
G When Do I Start FMEA? During project introduction? FMEA and Control Plans 5
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 1
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
A IEC 62304 safety classification, External Controls and off-label use related risks IEC 62304 - Medical Device Software Life Cycle Processes 5
S IEC 62304 software costs and time Medical Device and FDA Regulations and Standards News 3
S IEC 62304 - Software verification cost IEC 62304 - Medical Device Software Life Cycle Processes 3
Sravan Manchikanti Software Risk Management & probability of occurrence as per IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8

Similar threads

Top Bottom