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Recommended for Certification - R&D only (without Manufacturing or Marketing)!

yodon

Staff member
Super Moderator
#1
Hello Covers,

Just wanted to pass along some good news. We had our 13485 assessment audit last week and have been recommended for certification. What's interesting (I think) about it is that we are an R&D company; i.e., we don't sell or manufacture a medical device. Fortunately, we had an auditor that could think on his feet. We had to get a little creative in areas such as record management and advisory notices.

A few months ago, we had a pre-assessment against a system that did not really reflect our business practices. The auditor was quite concerned that we were heading down the wrong path. As a result, we completely overhauled our Quality System and passed the audit with only 3 minor NCs (2 were corrected before he left).

So for all those wondering if you can get certification despite selling or manufacturing: an emphatic yes!
 

BradM

Staff member
Admin
#3
Re: Recommended for Cert!

Yodon... thank you very much for the update! Especially from a fellow Texan!:bigwave: Maybe we're not as backwards as we look!:lol::lmao:
 
Y

yesyoucan

#4
Hello Covers,

Just wanted to pass along some good news. We had our 13485 assessment audit last week and have been recommended for certification. What's interesting (I think) about it is that we are an R&D company; i.e., we don't sell or manufacture a medical device. Fortunately, we had an auditor that could think on his feet. We had to get a little creative in areas such as record management and advisory notices.

A few months ago, we had a pre-assessment against a system that did not really reflect our business practices. The auditor was quite concerned that we were heading down the wrong path. As a result, we completely overhauled our Quality System and passed the audit with only 3 minor NCs (2 were corrected before he left).

So for all those wondering if you can get certification despite selling or manufacturing: an emphatic yes!
Research and development? 13485 assessment audit?

Very well. good work! :applause:

good luck! :agree1:
 

Roland Cooke

Quite Involved in Discussions
#5
Congratulations yodon, from a fellow...er...Texan. :D ;)

It's good to hear that your auditor showed flexibility, it's one of the things I really encourage when I train our auditors. I've been doing this job (on both sides of the fence) for nearly twenty years now, and I still learn something new everyday. Adapatability is king!


One of the things I would perhaps suggest you consider, if you didn't already is that Research, Design, and Development are actually three fairly distinct things.

Additionally RDD of processes/systems/equipment can be distinct from RDD of finished medical devices.

Do make sure that your QMS controls distinguish these things, if and as necessary.

Best regards,
Roland
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
Just wanted to pass along some good news. We had our 13485 assessment audit last week and have been recommended for certification. What's interesting (I think) about it is that we are an R&D company; i.e., we don't sell or manufacture a medical device. Fortunately, we had an auditor that could think on his feet. We had to get a little creative in areas such as record management and advisory notices.
Congratulations. Can you disclose the exclusions you took to ISO 13485 and the justification for the exclusions?
 

yodon

Staff member
Super Moderator
#8
Congratulations. Can you disclose the exclusions you took to ISO 13485 and the justification for the exclusions?
Sure. Exceptions included:

7.5.1.2 Control of production and service provisions - specific requirements - we don't get into manufacturing or packaging

7.5.2.2 Particular requirements for sterile medical devices - we don't get involved in sterilization / packaging.

7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices - we would not be the manufacturer, distributor, or company of record.

7.5.3 Identification and Traceability - we don't produce (manufacture) a product that could be sold (that would require id / traceability)

7.5.5 Preservation of Product - we would not be involved in preservation or shipping of manufactured product.

We tried to argue that we should be excluded from 8.3, control of nonconforming product for the reasons above, but the auditor wouldn't accept it. We only buy what we need to make prototypes and use what we buy immediately. If we have a "nonconforming" component, we return it or adapt it. to get the prototype to work. The auditor was ok with this since we do, I guess, technically handle it.
 

Roland Cooke

Quite Involved in Discussions
#9
Well of course you are not allowed to exclude from ISO13485 any of those things you just listed. ;):D

Only Design (7.3) can be excluded, and then only if regulations permit it.*

You can claim non-applicability to other sections with Clause 7 (only), with a substantiated justification.


If you manufacture a dental implant, say, to a design that has been around for 30 years, and the original design justifications were long disappeared, we would still expect, at the very minimum, procedures to enable controlled design change to take place if required, together with procedures to review at appropriate intervals the adequacy of the existing design against current clinical/technical knowledge.
 

Roland Cooke

Quite Involved in Discussions
#10
If we have a "nonconforming" component, we return it or adapt it. to get the prototype to work. The auditor was ok with this since we do, I guess, technically handle it.
And that, indeed, is your control of non-conforming product. At least your incoming raw materials. But don't forget that "product" is merely the output of a process, so it doesn't technically, even have to be a solid item.



Of course the other thing about prototypes is that they all (I guess except the very last iteration!) can be essentially described as non-conforming product. :D

You should have controls in place to stop (failed) Prototype X123 getting returned and mixed up with Prototype X124 (which has yet to be tested).
 
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