Who can certify compliance to IEC62304 of my Medical Device?

H

Houarcheneger

#1
Hi everybody !

I have just sent my new MD to be certified following the IEC60601-1 3rd edition.
I joint to the different files all the development process of the software according to IEC62304.
The answer of my NB was that it was not able to include the IEC62304 (neither clause 14 of general standard).

My questions are then: is this a problem for my CE marking? And, which NB is able to certify compliance with IEC6230?

Thanks a lot for your answers.

Houarcheneger.
 
Elsmar Forum Sponsor

sagai

Quite Involved in Discussions
#2
:applause:

spot on!

My recollection of the compliance with 62304 is similar to Santa claus, everybody are talking about it but no-one was actually saw him.

Regards
 

yodon

Staff member
Super Moderator
#3
I don't believe you can get certified to 62304. It's a standard for which, if you comply, you meet expectations of both FDA and NBs for properly controlling the software development process at the level commensurate with the risk. Similar to 14971 for risk management.

I'm not sure I understand your question / concern about your NB was "was not able to include the IEC62304." Can you explain?
 
H

Houarcheneger

#4
Hello Yodon,

Thanks for your answer. I understand I can not get "certification stamp" for 62304, however when I ask for a certification following 60601 ed. 3 standards (including 62304), NB automatically excluded 62304 because they were not able to evaluate compliance...

regards,

Houarcheneger
 

sagai

Quite Involved in Discussions
#5
one more thing ...

Did anyone ever come across with a warning letter or a NB audit report that contains reference to an ISO62304 clause as regard to non compliance?

Regards
 

yodon

Staff member
Super Moderator
#6
Did anyone ever come across with a warning letter or a NB audit report that contains reference to an ISO62304 clause as regard to non compliance?
Couldn't happen... it's a voluntary standard that supports presumption of conformity to the "real" requirements.

I take that back. If a company DOES state in their procedures that they shall comply with 62304 then an NB could write up an NC if they didn't comply.
 

Peter Selvey

Staff member
Super Moderator
#7
In theory it could be possible to be certified to IEC 62304, on the basis of an audit similar to ISO 13485 and other system standards. However, at this stage there is no system set up in the medical world to support such certification. Such a system would address the issues of training and qualification of the auditor, how many man days are required, what audit records are required, the extent of sampling, frequency of follow up audits, action in case of non-compliance and so on.

Without such a system, it would be wise for any testing agencies to exclude Clause 14, PEMS and IEC 62304, especially for higher risk devices. If they charge a fee for it, that places them in the path of responsibility in case anything goes wrong. Under ISO 17025, a test laboratory is a entity that can be held responsible. If there was a agreed audit system in place, and the laboratory followed the system, they can avoid responsibility. But without such a system, they are in no mans land, a legal minefield.

What's the impact? Generally, when you get to the real regulatory audit or application for the final medical device, compliance with IEC 62304 could be picked out as a subject for review. So you still have to have the records anyway, even if a test laboratory excluded it. In theory, if the test lab included Clause 14 and IEC 62304, the regulatory reviewer might trust this, rubber stamp and move on to the next subject. But a good reviewer will know that the test labs are not really experts in PEMS/software, so they might dig into the detail whether or not the report covers Clause 14.
 

c.mitch

Quite Involved in Discussions
#8
To answer yodon's post #6 in this thread.
I already saw NB raising non conformities about software but only because the manufacturer wasn't able to demonstrate that he is compliant with essential requirements about software validation.
The NB won't raise a NC on IEC 62304 unless the manufacturer claims that he is compliant with this standard.
Devil is in the details! :D
 
B

Bill Watson

#9
We are looking at registro for Brazil, and have been asked for an IEC62304 report as part of the submission. Based on the discussions above, this will have to be an internal report. Has anyone had any experience of Brazil and submitting an IEC62304 report. Would you use a TRF from the IEC or is any format acceptable?

FYI, our NB for Europe gave us the following NC "The requirements of Clause 7.1 Planning of product realization were not fully met, in that the software management standard, IEC62304:2006 was not being applied."

The rationale they used was that IEC62304 is now best practice and so it is expected it be applied. Has anyone had similar experiences? Our development processes meet FDA, 13485, etc etc and they did not raise any NCs related to our development process, just that we were not applying 62304.
 

c.mitch

Quite Involved in Discussions
#10
Hello
I don't have the answer about Brazil. But I think you could have disputed the NC raised by the NB. IEC 62304 is an harmonized standard and is applied on a voluntary basis.
 
Thread starter Similar threads Forum Replies Date
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 2
L In house calibration - Our CMM's are outside certified can I use them to certify our standards General Measurement Device and Calibration Topics 4
E Correct way to certify hydrostatic testing when it is not 100% (and Sample Size) Various Other Specifications, Standards, and related Requirements 6
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
S EU conformity assessment - Certify to MDD or MDR? EU Medical Device Regulations 3
M CE self-certify, or needs testing by 3rd party? CE Marking (Conformité Européene) / CB Scheme 12
B How to certify a Class IIa Medical Device CE Marking (Conformité Européene) / CB Scheme 1
B ISO 13485 certification advantages when I certify a Class 2a medical device CE Marking (Conformité Européene) / CB Scheme 12
A Looking to certify to ISO 9001 - Any advice? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Timing to certify new plant to IATF 16949 IATF 16949 - Automotive Quality Systems Standard 2
L In which country do I certify my company? (ISO 13485) ISO 13485:2016 - Medical Device Quality Management Systems 14
M Do I need to certify to ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 5
N Do I need to certify to AS9100 or AS9120? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
F Can a certified welder certify other welders? Training - Internal, External, Online and Distance Learning 8
drgnrider Certify to new ISO 14001 standard or stay with current standard? ISO 14001:2015 Specific Discussions 8
S Does NIST Certify Calibration Laboratories? General Measurement Device and Calibration Topics 4
B CB Certify OHSAS 18001:2007 without AB - Why CB no need AB? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
S Does UL certify manufacturers of storage tanks? Manufacturing and Related Processes 4
P CBs are not permitted to certify to AS9100 Rev C until 2011? True or False? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
Q ISO 9001 Standard: Useful to Certify a Soccer Club? Examples... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 45
E How long does it take to certify a scope extension? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
somashekar Factory Inspection to Register and Certify a Medical Device in Brazil Other Medical Device Regulations World-Wide 35
S Good Tissue Practice (GTP) - Certification Bodies which are qualified to Certify it. Other ISO and International Standards and European Regulations 0
H Creating a Sub Company to Certify One Product Line ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
H Is it possible to only certify manufacturing when we do everything else too? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C Conventional Mass vs. Nominal Mass - Certify the in-house balances General Measurement Device and Calibration Topics 9
J Aftermarket - OEM - OES - Certify to TS16949 IATF 16949 - Automotive Quality Systems Standard 5
D 17025 - I am looking for someone to come in and certify our laboratory equipment ISO 17025 related Discussions 1
D Certification of Suppliers- a requirement or semantics??? comply, certify Supplier Quality Assurance and other Supplier Issues 11
M We have to have a written request from an automotive customer requiring us to certify IATF 16949 - Automotive Quality Systems Standard 1
S Can we use ISO 9004 to certify? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Can a trained person in our lab "certify" a piece of steel gauge General Measurement Device and Calibration Topics 3
E Accredited vs. non-accredited labs for 60601 compliance in the US IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Accredited vs. non-accredited labs for 60601 compliance in the US Other Medical Device Related Standards 0
M Class II type machine , and its compliance with 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
H Automotive wires - Compliance with USCAR21-4 & USCAR38-1 Various Other Specifications, Standards, and related Requirements 0
M FULFILMENT of compliance obligation versus COMPLY with compliance obligations ISO 14001:2015 Specific Discussions 2
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2
D HIPAA, HITECH and Interoperability compliance route Medical Device and FDA Regulations and Standards News 2
A Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3
M Tracking Expiration dates on compliance certifications REACH and RoHS Conversations 2
T Training recommendations? Bringing our RoHS and REACH compliance efforts in-house REACH and RoHS Conversations 2
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
G ISO 14001 - 6.1.3 Compliance Obligations ISO 14001:2015 Specific Discussions 1
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3

Similar threads

Top Bottom