QA approval for Medical device testing?

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How much QA approval or signature is important for medical device testing reports. Can anyone please explain?

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Posted by Van Daana Kp (Discussions: 1, Comments: 0)
Replied on April 4, 2016 10:45 am
Category: Medical Devices
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If you research the FDA website for Design Control Guidance for medical device manufacturers you can find answers to exactly what you are looking for in your view! Corporations should have a baseline on paper and then make improvements based on the history to include such things as failures!
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Posted by Anonymous (Discussions: 0, Comments: 4)
Replied on April 4, 2016 10:48 am
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Beyond the FDA regulations and guidance mentioned by Anita Medlin, you must comply with your own approved procedures. If this is not clearly defined in your SOP's you should make sure they get added.
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Posted by Samuel Linton (Discussions: 0, Comments: 1)
Replied on April 6, 2016 4:48 pm
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Van Daana Kp If I'm reading your question correctly, you're asking about a "quantity" of QA approval needed for reports? If this is what you are asking then you need to take a step back and look at the protocol that was written first. QA should be an approver on the protocol of the testing, study, validation, verification, etc. Whoever was required on the protocol should be the same person(s) who sign on the report. As far as how many QA signatures are needed, that depends on the subject matter, the risk involved, and how many managers WANT to sign off on the documents. From my perspective, the minimum amount of signatures you need on any manufacturing or R&D protocol/report would be three: the author of the document, a Quality Unit representative, and the supervisor/manager/owner of the product/process. You may add any others that you feel would be prudent (Medical Officer, supplier representative, etc.), but most times I feel the three signatures are enough.
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Posted by Mark Proulx, BSc, CQA, cSSBB (Discussions: 1, Comments: 39)
Replied on April 7, 2016 3:02 pm
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Is there a legal minimum? Or does it only depend on what you have written in your quality management system?
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Posted by John Brouwers (Discussions: 0, Comments: 1)
Replied on April 7, 2016 10:02 pm
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John Brouwers No, there is no "legal" minimum. The FDA's stance is the manufacturer must take into account the risk in all things and put as many controls into place as is prudent to reduce or eliminate risk as much as possible. If controls mean that you need to add more signatories to approvals (which, in my experience has NEVER been a level of control), then so be it. A better level of control would be a well planned out validation plan and execution to ensure the proper things are being tested for and that you have qualified people approving protocols and reports. If management is truly engaged, there should be metrics (KPIs) that tell management that the Quality System is functioning as intended. The individual reports must move the product development forward but there is no regulation as to how many approvers you must have to ensure that the testing was planned and executed properly.
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Posted by Mark Proulx, BSc, CQA, cSSBB (Discussions: 1, Comments: 39)
Replied on April 8, 2016 6:02 pm
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Thanks everyone for responding back. I understand my question wasn't really clear. I actually meant was Do QA in medical device testing contracting companies should play a role in signing/assuring the GMP compliance for the the final reports submitted to their clients? Is it a mandatory/regulatory rule or just depends on company to company procedures?
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Posted by Van Daana Kp (Discussions: 0, Comments: 2)
Replied on April 8, 2016 6:02 pm
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Thanks Mark Proulx,.
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Posted by Van Daana Kp (Discussions: 0, Comments: 2)
Replied on April 8, 2016 7:02 pm
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as far as I know the only places where QA review is mandated is for GLP studies
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Posted by Sri Vishnubhotla (Discussions: 0, Comments: 6)
Replied on April 9, 2016 4:02 am
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In both ISO and FDA QSR the firm placing the medical device in the market is responsible to determine and then carry out the appropriate testing to make certain the design is safe and effective as well as the manufactured products using that design conform to specifications. In some cases third party testing (for example electrical safety, emc, biocompatibility) is routinely outsourced to contract labs. The device manufacturer is still however fully responsible for the quality of those tests and reports. It would be a serious lapse of a manufacturer not to review-critically review in fact all third party test reports. From the test lab side, yes they are required to review their reports to comply with ISO 17025 among others and again, the liability for an unreviewed report would be tremendous as it could result in recalls and lawsuits.
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Posted by Richard Reeves (Discussions: 0, Comments: 1)
Replied on April 10, 2016 2:02 am
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You're most welcome Van. This does open up another point that Richard Reeves brings up and that is Supplier Qualification. This is huge when it comes to third party testing and certification. Your company needs to look at how well your vendors and suppliers have been vetted, how often you audit them to see that they are staying in compliance, and are meeting the agreements you've signed to deliver quality product.However they sign off (whether one signature or multiple), the discussion has to be had and agreed to as to what they will deliver every time so your responsibilities as manufacturer are met.
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Posted by Mark Proulx, BSc, CQA, cSSBB (Discussions: 1, Comments: 39)
Replied on April 12, 2016 7:13 pm
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