Even after having a few years of experience as a QA Officer, it's always nice to go back to the basics and make sure you have a solid foundation. Thanks for the great video !
Great VideaHow to address ISO 13485 for a medical software involving AI, writing clear requirements and testing requirements are often not so straightforward. Any guidance on that?
what are the thingsg i need to get ready before approaching a notified body for an audit? The ISO has the standards set out for 100-200 euro, but does the EU MDR (for CE marking) have a similar document?
For EU MDR it is free. You just write EU MDR 2017/745 on google and you have the regulation in the EUROPA website. For preparation to an audit, we have created an audit readiness training on our course page. Check it out
@@EasyMedicalDevice Hi Mounir, tried to find your email but cannot seem to find it, only linkedin, isntagram and twitter. Thank you so much for your helpful videos and replies. I have a few more questions, wondering if you could help with these? 1) From what I understand, a consultant can help get all the documents ready and the PRRC would then make sure everything is in place before communication with a notified body, but I do not need to have everything ready to get in touch with a notified body as all these things should happen in parallel given the wait times for notified body audits? If the PRRC has to be on-retainer but only reviews all documents prior to notified body, what is the point of having him/her on retainer? 2) What does your company do specifically, and how much do you charge? 3) Realistically, what will I be able to do in terms of documentation preparation for ISO and CE marking? If I purchase your template, and the course, will I be able to look through the entire ISO and EU MDR documents and get the documents ready? Seems like it is a lot of work 4) Does the company apporach a notified body or does it have to be certified person eg a PRRC 5) The company is from Singapore and are looking into getting HSA (Singapore regulation) certified. Given the crossover of all the standards (eg ISO, CE, UKSA), if the product is Singapore HSA certified, will it be quick to adapt those documents to the CE/ISO marking (and for other countries eg Saudi etc) Similarly, is there any time saving/cost saving available if you are certified in another country? 6) What is the timeline for the entire CE/ISO marking - ie from preparing the documents, getting a company to audit, getting PRRC to audit, and then finally notified body to audit? 7) What are the estimated costs for the entire process? You quoted 15-30 000 euros. Is this including a consultant to get documents ready, PRRC, notified body? And if I understand correctly, it is a recurring 30k euro payment given CE marking is only for 3 years? 8) Is there anything (apart from preparing the documents now), that can be done to expedite the process? In terms of 'preparing the documents', does your audit course deal with everything that needs to be done prior to hiring a PRRC? Will the PRRC also help get documents in place? 9) Operationally for the company, is there anything that needs to be done to prepare for this? Thank you so much Monir! I am thinking of using your company, for the audit course and also at some point perhaps for consulting to ensure all documents are in place. I can send you an email if you wouldn't mind giving me your email. Thank you for taking the time to reply!!
Thx for wonderful video, My question: The acceptance and recognition of ISO 13485, got from NB or CB will it be same,??? specially for EU market and secondly for America??? and about renewal cost will be at same as initial cost?
Hi Asim, yes if this comes from a Notified Body or a Certification Body this is the same. Both are accredited for that. But if you are also requiring CE certification then you should get both from the Notified Body as they will ask you to have this certificate under their organization. They will not accept one from another. And the cost should be the same yes.
Thanks for the video.. very informative.. Have one question that if a company involved only in verification of Medical product, is ISO13485 mandatory? whether ISO9001 + some tailored SOPs enough to execute such job?
Notified Bodies are designated by competent authorities and the EU to certify companies on legislation like EU MDR. A certification Body is a company that is accredited to certify you on a standard like ISO 13485. A notified body is usually also a certification body as they can certify you on ISO 13485. But a certification Body is not automatically a Notified Body.
Thank you for the very informative video. I've already subcribed to your channel and will watch all of your videos eventually. I have one question for you. We are a small US company and would like to sell our product in the EU. Our products are class 2 Medical Device. Would you recommend that we get CE Mark with a Notified Body or to get ISO13485 in order for us to be able to sell our products in the EU? Of note, we are not yet ISO 13485 Certified. Thank you for your reply.
Hi Brandon For your company to be able to commercialise the products in EU and being class2 the product will need to be CE marked with a Notified Body. You will also require an ISO 13485 certificate with the same Notified Body You will also require an authorized representative in the EU to be able place your product on the EU market. the CE cert will be renewed every 5 years and the ISO cert will be renewed every 3 years.the notified body will carry several audits at the manufacturer
Hi, you can certify a software company but you still beed to receive the auditor at the address where is located your company if this is a first time audit. As they need to put an address they have to verify that you really exist. So this may be discussed with the Certification Body
![Training Procedure: "Mistakes to avoid and audit advice" [ISO 13485]](http://i.ytimg.com/vi/b95StmiXIJQ/mqdefault.jpg)
![Training Procedure: "Mistakes to avoid and audit advice" [ISO 13485]](/img/tr.png)
Even after having a few years of experience as a QA Officer, it's always nice to go back to the basics and make sure you have a solid foundation. Thanks for the great video !
Best video on ISO13485 so far, keep it up Monir!!
Thanks Saheb, really appreciated.
Great VideaHow to address ISO 13485 for a medical software involving AI, writing clear requirements and testing requirements are often not so straightforward. Any guidance on that?
what are the thingsg i need to get ready before approaching a notified body for an audit?
The ISO has the standards set out for 100-200 euro, but does the EU MDR (for CE marking) have a similar document?
For EU MDR it is free. You just write EU MDR 2017/745 on google and you have the regulation in the EUROPA website. For preparation to an audit, we have created an audit readiness training on our course page. Check it out
@@EasyMedicalDevice
Hi Mounir, tried to find your email but cannot seem to find it, only linkedin, isntagram and twitter.
Thank you so much for your helpful videos and replies.
I have a few more questions, wondering if you could help with these?
1) From what I understand, a consultant can help get all the documents ready and the PRRC would then make sure everything is in place before communication with a notified body, but I do not need to have everything ready to get in touch with a notified body as all these things should happen in parallel given the wait times for notified body audits? If the PRRC has to be on-retainer but only reviews all documents prior to notified body, what is the point of having him/her on retainer?
2) What does your company do specifically, and how much do you charge?
3) Realistically, what will I be able to do in terms of documentation preparation for ISO and CE marking? If I purchase your template, and the course, will I be able to look through the entire ISO and EU MDR documents and get the documents ready? Seems like it is a lot of work
4) Does the company apporach a notified body or does it have to be certified person eg a PRRC
5) The company is from Singapore and are looking into getting HSA (Singapore regulation) certified. Given the crossover of all the standards (eg ISO, CE, UKSA), if the product is Singapore HSA certified, will it be quick to adapt those documents to the CE/ISO marking (and for other countries eg Saudi etc) Similarly, is there any time saving/cost saving available if you are certified in another country?
6) What is the timeline for the entire CE/ISO marking - ie from preparing the documents, getting a company to audit, getting PRRC to audit, and then finally notified body to audit?
7) What are the estimated costs for the entire process? You quoted 15-30 000 euros. Is this including a consultant to get documents ready, PRRC, notified body? And if I understand correctly, it is a recurring 30k euro payment given CE marking is only for 3 years?
8) Is there anything (apart from preparing the documents now), that can be done to expedite the process? In terms of 'preparing the documents', does your audit course deal with everything that needs to be done prior to hiring a PRRC? Will the PRRC also help get documents in place?
9) Operationally for the company, is there anything that needs to be done to prepare for this?
Thank you so much Monir!
I am thinking of using your company, for the audit course and also at some point perhaps for consulting to ensure all documents are in place.
I can send you an email if you wouldn't mind giving me your email.
Thank you for taking the time to reply!!
Thx for wonderful video, My question: The acceptance and recognition of ISO 13485, got from NB or CB will it be same,??? specially for EU market and secondly for America??? and about renewal cost will be at same as initial cost?
Hi Asim, yes if this comes from a Notified Body or a Certification Body this is the same. Both are accredited for that. But if you are also requiring CE certification then you should get both from the Notified Body as they will ask you to have this certificate under their organization. They will not accept one from another. And the cost should be the same yes.
Thanks for the video.. very informative.. Have one question that if a company involved only in verification of Medical product, is ISO13485 mandatory? whether ISO9001 + some tailored SOPs enough to execute such job?
If you are doing some quality check of the devices so you need ISO 13485
But mainly if you are the legal manufacturer
In 7:45 you say "No, not Class 1, because Class 1 doesn't need..." I didn't understand what you say there. Can you please repeat? Thank you!
What is the dif. Between notified body and certification body ?
Notified Bodies are designated by competent authorities and the EU to certify companies on legislation like EU MDR. A certification Body is a company that is accredited to certify you on a standard like ISO 13485. A notified body is usually also a certification body as they can certify you on ISO 13485. But a certification Body is not automatically a Notified Body.
Thank you for the very informative video. I've already subcribed to your channel and will watch all of your videos eventually. I have one question for you. We are a small US company and would like to sell our product in the EU. Our products are class 2 Medical Device. Would you recommend that we get CE Mark with a Notified Body or to get ISO13485 in order for us to be able to sell our products in the EU? Of note, we are not yet ISO 13485 Certified. Thank you for your reply.
Hi Brandon For your company to be able to commercialise the products in EU and being class2 the product will need to be CE marked with a Notified Body. You will also require an ISO 13485 certificate with the same Notified Body
You will also require an authorized representative in the EU to be able place your product on the EU market. the CE cert will be renewed every 5 years and the ISO cert will be renewed every 3 years.the notified body will carry several audits at the manufacturer
Can you certify a virtual business? Thank you
Hi, you can certify a software company but you still beed to receive the auditor at the address where is located your company if this is a first time audit. As they need to put an address they have to verify that you really exist. So this may be discussed with the Certification Body
Brilliant video
Thanks!
Thank you!
Thanks Moin for your support
Nice video. Thank you!
NEHA KHOT happy you enjoyed it
Very informative!
Nice keep it up
Zumar Instruments ltd thanks. Really appreciated.