Girl atleast put some life in your speaking style- tbh was so dull and a drufgery to sit through
@pdsCVАй бұрын
Reasonably forseeable misuse: Because..people..
@shreethoka24902 ай бұрын
Great video!
@jackejr744 ай бұрын
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....
@danmarquez39714 ай бұрын
Thank you for the GREAT seminar!! Everything was clear, concise, logical, and easy to understand.
@brantley78314 ай бұрын
😘 "promo sm"
@cnstherapy13215 ай бұрын
Wonderful presentation Thanks
@jingwan-mc8yf5 ай бұрын
COOL
@larrystevens34689 ай бұрын
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.
@leanRAQA9 ай бұрын
I guess I need to clarify the point of this video, @larrystevens3468, because it was meant to be funny, NOT educational. I know that silicone is safe to use, but apparently this client did not. But thanks for pointing it out.
@Sattva46810 ай бұрын
You know it’s gonna be good when it starts with “FDA’s insane draft guidance” 😆
@FikosoEva-lz2kq Жыл бұрын
“I would if i could but it aint cause i cant”
@pdsCV Жыл бұрын
QA people getting cut first: It's why I'm job hunting now. Sudden cut with no warning.
@pdsCV Жыл бұрын
Executive team and/or software folks are often the biggest offenders!
@robertbolding4182 Жыл бұрын
So the auditor was enjoying the company of the two ladies. It sounds to me like the payoff he was expecting didn't happen
@leanRAQA Жыл бұрын
Generally I would agree with you, but in this instance there was me and the other leanTeam member was male and the client was female but very pregnant. I think he had was in semi-retirement and was lonely. We were the closest thing to a friend he had at the time!
@MedicalMarcom Жыл бұрын
This is an excellent resource. I'm sharing it with my Medical Devices Group (360,000 members), thank you!
@alexdespotovic1698 Жыл бұрын
This is a really useful presentation, thank you :)
@leanRAQA Жыл бұрын
Glad it was helpful! And I'm sorry it took me so long to send a response. 😁
@treythorsen225 Жыл бұрын
This is a FANTASIC video. It explains the complicated Design Control and Risk Management process in a way that's easy to understand!!!
@madhuvantipatil47082 жыл бұрын
I love your channel. It must be a lot of work to put out content but thank you for sharing this knowledge.
@leanRAQA Жыл бұрын
Thank you - I appreciate that! It is a lot of work, but I enjoy it.
@yammer44692 жыл бұрын
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.
@leanRAQA2 жыл бұрын
Thanks for the feedback! MDR is a complete disaster, and I'm not sure what can fix it at this point. Extending MDD may help but may also give manufacturers another excuse not to pursue MDR certification. It's a mess.
@Sattva4682 жыл бұрын
Excellent presentation. Thank you!
@leanRAQA2 жыл бұрын
Glad it was helpful!
@midomado91922 жыл бұрын
Thanks for sharing! Do you have an episode of IVDR-legacy devices? Thanking you!
@leanRAQA2 жыл бұрын
No, sorry, I don't. I'm not doing much with IVDR so do not know too much about it.
@larrystevens34683 жыл бұрын
5 minutes in and still don't know what the product is.
@leanRAQA2 жыл бұрын
That may be an editing goof, Larry, or the result of two friends catching up. Stephanie has developed a simple, weighted device to help women strengthen their kegel muscles more effectively.
@saurabh55343 жыл бұрын
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.
@leanRAQA2 жыл бұрын
I'm sorry for my severely delayed reply, Sarabh, but this is tool complex a question to address here. If you still have questions, please visit our website and put some time on my calendar and we can discuss - thanks.
Пікірлер
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.
I guess I need to clarify the point of this video, @larrystevens3468, because it was meant to be funny, NOT educational. I know that silicone is safe to use, but apparently this client did not. But thanks for pointing it out.
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
Generally I would agree with you, but in this instance there was me and the other leanTeam member was male and the client was female but very pregnant. I think he had was in semi-retirement and was lonely. We were the closest thing to a friend he had at the time!
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 :)
Glad it was helpful! And I'm sorry it took me so long to send a response. 😁
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.
Thank you - I appreciate that! It is a lot of work, but I enjoy it.
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.
Thanks for the feedback! MDR is a complete disaster, and I'm not sure what can fix it at this point. Extending MDD may help but may also give manufacturers another excuse not to pursue MDR certification. It's a mess.
Excellent presentation. Thank you!
Glad it was helpful!
Thanks for sharing! Do you have an episode of IVDR-legacy devices? Thanking you!
No, sorry, I don't. I'm not doing much with IVDR so do not know too much about it.
5 minutes in and still don't know what the product is.
That may be an editing goof, Larry, or the result of two friends catching up. Stephanie has developed a simple, weighted device to help women strengthen their kegel muscles more effectively.
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.
I'm sorry for my severely delayed reply, Sarabh, but this is tool complex a question to address here. If you still have questions, please visit our website and put some time on my calendar and we can discuss - thanks.