Software Toolkit for Medical Imaging - Need to claim conformance to EN 62304?

M

medconn

#1
We a very small software house who have for many years sold a software toolkit for medical imaging, but do not sell final user products. Until recently, all the regulatory issues have been handled by our customers, on the basis that however good (perfect?) our tookit is, the responsibility for the integration and testing of the final product is solely theirs. However, in the last few months, we have been receiving requests for documentation to show that our toolkit is a fit and proper component in their products, and I need to know how to proceed. My current guesses (based on reading, but no expertise) are that:
  • We need to claim conformance to EN 62304
  • We should have suitable internal processes to back up that claim
  • EN 62304 does not require external auditing
  • We don't require a formal quality system (and the army of staff to write the paperwork!) for EN 62304 (this is based on the afct that EN 62304 has a checklist specifically for companies without a formal ISO 9000 derived Quality system!)
  1. Am I right on all the above, or have I been too optimistic?
  2. Will I need to take on multiple other people just to write bits of paper?
  3. How should I get started on this road?
Help and advice much appreciated!

Dave
 
Last edited by a moderator:
Elsmar Forum Sponsor

glork98

Involved In Discussions
#2
Perhaps your answer is here.
http://elsmar.com/Forums/showthread.php?t=43948

Also, you're pessimistic on the work it takes to be 62304 compliant. It's not bad if you're doing professional work already. If you're hacking code together, then it's a long slog. "bits of paper" misses the point of doing good engineering work. The additions are documenting that you're going to design and test intentionally and thoroughly and providing the evidence that you actually did it.
 
M

medconn

#3
Hi,

Thanks for the pointer to that thread - it is certainaly a very similar use case to ourselves, but doesn't have the answers to my specific needs about the needs for formal QMS accreditation and/or other external auditing - through those questions were raised in the thread. Does anyone have any answers on those questions?

Actually, I'm trying to be optimistic about the requirements, and as you point out, many of the requirements are simply good practice, but my experiences of ISO 9000 derived QMS processes, back from the days when I worked with a hospital department which went that route were very bad - they simply did exactly what they'd done before, with no improvements, but they then needed an extra member of staff just to file the documents they produced - so perhaps I have an unduly bad experience of the viral aspects of QMSs!

Dave
 
S

SayDo

#4
Dave,

In order to claim compliance to IEC/EN 62304, see clauses 1.4 and 4.1 of the standard. The IEC/EN 62304 standard is not a standalone thing; it is meant to be used in conjunction with other quality processes.

My understanding is that you must have a quality system in place (clause 4.1) and there are expectations as to what that quality system will conform to. Whether you attempt to have that quality system certified by a third party or not is up to you, but your customer should be telling you what their quality expectations are. I would expect that your customer would either audit you themselves or express a desire that you obtain third party certification.

The quality system should provide the basis for establishing evidence that you need to claim conformance to IEC/EN 62304. Additionally, it should identify that you are conforming to IEC/EN 62304. Your claim of conformance is enough to subject your IEC/EN 62304 evidence to whatever external audit your customer needs.
 
M

medconn

#5
Hi,

Thanks for the input - I think the pattern is slowly starting to gel in my mind! I was thrown by the apparent conflict between 4.1:

"NOTE 1 Demonstration of this ability can be by the use of a quality management system that complies with:
- ISO 13485 [7]; or
- a national quality management system standard; or
- a quality management system required by national regulation."​
and D.5:​

Checklist for small MANUFACTURERS without a certified QMS.​
I suppose, puttng this together we end up with the phrase I had missed in D.2:​

This standard does not require that the QMS necessarily has to be certified.

So - we DO need a QMS of some variety, but certification of it is between me and my customers. Is that right?


Dave

 
S

SayDo

#6
Yes! You got it.

Your customer will be regulated and have particular regulatory requirements that they must comply with since they are the "manufacturer" of the finished medical device. If they are doing their job properly, they should be assuring that your work products are developed in conformance with their needs. So, the "variety" of QMS that you establish should address their requirements to you.
 

Peter Selvey

Staff member
Super Moderator
#7
Just to answer the original questions one by one:
  • We need to claim conformance to EN 62304
No, EN 62304 is a standard that applies to the manufacturer of the actual medical device. It is not applicable to third parties. However, the manufacturer may reasonably ask you (e.g. in a contract) to provide documentation to help them establish compliance. If you are dealing with several end product manufacturers it makes sense to prepare the paperwork in advance, using declared assumptions such as the Class of software or expected (typical) software risk control measures. But you should avoid stating compliance with the whole standard.
  • We should have suitable internal processes to back up that claim
Again, it makes sense to have those processes and evidence of those processes (such as version control) that helps the end product manufacturer make a claim of compliance.
  • EN 62304 does not require external auditing
True. The manufacturer may be audited, and where justified the law allows auditing of third party manufacturing sites (subcontracted production), but not third party design sites. The notified body must however audit the manufacturer's control of your site. If all parties agree (notified body, manufacturer and third party) it can be more convenient to be directly audited. If there is confidential information, there may be a stalemate that can only be broken if you open yourself for a direct audit. You can also make yourself available to travel to the site of the manufacturer if requested.
  • We don't require a formal quality system (and the army of staff to write the paperwork!) for EN 62304 (this is based on the afct that EN 62304 has a checklist specifically for companies without a formal ISO 9000 derived Quality system!)
Agree, no formal quality system is required. An ISO 9001 system might help, provided that it was streamlined for software development company.

Hope this helps.
 
M

medconn

#8
Many thanks - the perfect answer to my question. In effect it puts us back to exactly where I started the whole issue (that regulatory compliance only affects products rather than components), but with much more understanding on my part of where EN 62304 fits into the picture.

:thanks:
 

sagai

Quite Involved in Discussions
#9
IEC62304 and ISO14971 gives details for medical device manufacturers about FDA's quality management system requirements for Design Control when the medical device contains software.
 

glork98

Involved In Discussions
#10
In effect it puts us back to exactly where I started the whole issue (that regulatory compliance only affects products rather than components)
I'm sensing hands being washed. Regulatory compliance is on everything in the product and all the tools used to create the product. The manufacturer has this responsibility so component providers can ignore it. Component providers that are cognizant of their customers' needs can get more sales or a price premium for their foresight.
 
Thread starter Similar threads Forum Replies Date
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
Y Software updates considered servicing (7.5.4) ISO 13485:2016 - Medical Device Quality Management Systems 4
S How to perform verification of the Statistical Analysis Software? Qualification and Validation (including 21 CFR Part 11) 2
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
L Micro-Vu InSpec Software Program Qualification and Validation (including 21 CFR Part 11) 6
A For software change - New Channel of interoperability CE Marking (Conformité Européene) / CB Scheme 4
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C SharePoint Contract Management Software General Information Resources 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
B Complaint Records - Accessing records on Easy Track Software Records and Data - Quality, Legal and Other Evidence 3
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
D Safety data sheets software REACH and RoHS Conversations 2
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Missing 1m visual alarm signal in case of software/display failure, mitigation? ISO 14971 - Medical Device Risk Management 3
B Software service provider as critical supplier ISO 13485:2016 - Medical Device Quality Management Systems 5
S Asterisk in DOE minitab software Using Minitab Software 23
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 1
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2
bruceian Software Quality Metrics Software Quality Assurance 11
optomist1 How Secure Are Our Software Systems Software Quality Assurance 7
M 'Active' device? Software/laptop with attached camera 'looking' at passive metal probe EU Medical Device Regulations 3
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
L Radiology software Class I exemption Medical Device and FDA Regulations and Standards News 3
O Software for comparing text of PDF files Contract Review Process 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 2
M Recurrent event analysis software (python) General Auditing Discussions 2
Y UL 1998 Standard: software classes Software Quality Assurance 0
P Need a programmer for QVI's VMS software for optical inspection machine Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
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
I Form templates for software (iso9001) Document Control Systems, Procedures, Forms and Templates 0
H Software Interface Translation IVD Regulation EU Medical Device Regulations 0
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3

Similar threads

Top Bottom