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Hello. At time 25:56 you show that Drawings go in the DMR, this is not quite correct. Work instructions, yes but not component and assembly drawings that drive the creation of the work instructions. Drawings may be in the work instructions but, the WHAT is to be made, is in the DHF. I'm in the middle of an audit at the moment and this was made VERY CLEAR me. DHF -What is to be made. DMR - How to make it. DHR - What was made.

Thank you for the video. I have a question regarding medical devices like dermal fillers-are they typically classified as Class I or Class II? I am interested in registering a brand from Europe that is CE marked and has been in the market for over 20 years. There are two product lines I’m looking to distribute in the USA. One of the products is similar to other FDA-approved dermal fillers, and the other is an innovative body filler for butt augmentation. Contrary to popular belief, body fillers have been used safely in Europe for many years and are considered safer than traditional fat transfer and some other FDA-approved methods. I would appreciate hearing your opinion on this matter.

Is 510k documents needed for ultrasonic dental tartar removal machine?

Girl atleast put some life in your speaking style- tbh was so dull and a drufgery to sit through

Reasonably forseeable misuse: Because..people..

Great video!

In my QA/RA Consulting work around the world, I encountered auditing/consulting companies (not Notified Bodies nor Competent Authorities) that were "selling" auditing services and issuing "Certificates of Compliance for ISO 13485:2016 Quality Systems" without authorization to do so from a Competent Authority (nor being affiliated with a Notified Body). From My First hand experience, I performed a Due Diligence audit in a Headquarters (combined with a Manufacturing Facility) for a group of investors; at the same time another "auditor" was there performing an ISO 13485:2016 audit. The other auditor departed after only two days of auditing and issued the Company a Certificate of Compliance to ISO 13485:2016 with NO FINDINGS and an invoice for auditing services. I completed my "Due Diligence Audit" in five (5) Days (taking a little extra time looking for some evidence of compliance) and issued the Head of the Group of Investors (and ultimately the Top Executive of the audited company) an audit report, failing the entire Quality System as Non-Functioning for many Top Level SOPs not in place, not implemented, not documented, with no Design Controls, no test equipment calibrations and most other QMS sub-systems not functioning (not going into more detail here on purpose). In addition, no person in the entire audited company had any medical device Quality System Experience (not even the Quality Manager). NOTE: These unauthorized Quality System auditing companies are preying on Medical Device Companies that do not know any better and we need to do a better job of educating the industry about these fake auditing organizations! I requested a short meeting with the Top Executive in the Facility I audited and told him about my concerns, that he is paying for worthless Quality System auditing services. He Thanked Me, we shook hands and I departed, hoping I did the right thing....

Thank you for the GREAT seminar!! Everything was clear, concise, logical, and easy to understand.

😘 "promo sm"

Wonderful presentation Thanks

COOL

A nasty rumor. Silicone has been used to make millions of human implants for over 50 years. Of course it must be silicone compounded to meet biocompatibility requirements.

You know it’s gonna be good when it starts with “FDA’s insane draft guidance” 😆

“I would if i could but it aint cause i cant”

QA people getting cut first: It's why I'm job hunting now. Sudden cut with no warning.

Executive team and/or software folks are often the biggest offenders!

So the auditor was enjoying the company of the two ladies. It sounds to me like the payoff he was expecting didn't happen

This is an excellent resource. I'm sharing it with my Medical Devices Group (360,000 members), thank you!

This is a really useful presentation, thank you :)

This is a FANTASIC video. It explains the complicated Design Control and Risk Management process in a way that's easy to understand!!!

I love your channel. It must be a lot of work to put out content but thank you for sharing this knowledge.

This is a great presentation. Why are we letting this happen? When something fails, you fix it. One fix would be an extension of MDD and a post-mortem review of MDR (before it is reimplemented). I know failure is a difficult pill to swallow but this is going from bad to worse. It's only early 2022 and there are many manufacturers that no longer have access to Europe and UK.

Excellent presentation. Thank you!

Thanks for sharing! Do you have an episode of IVDR-legacy devices? Thanking you!

5 minutes in and still don't know what the product is.

Hi Thanks for the beautiful presentation. Could you please help with my doubt ? For any 510k we need predicate. If suppose, I am changing my device intended use totally - in that case, how could I select predicate device? I mean, if I am having a new intended use and for that no predicate available, dont you think I shall go for new route may be PMA or DeNovo. Kindly respond.