To help the Medical Device Community having a better understanding of the Medical Device Regulations and Standards I decided to create Videos.
I really wish this provides you value.
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Classification Medical Device in EU (Medical Device Regulation MDR 2017/745)
What Is a Medical Device? (New Medical Device Regulation MDR 2017/745)
Medical Device Regulation Transition Timeline (MDR 2017/745)
Within less than 10 minutes you’ll learn how to classify a Medical Device in Europe with the new Medical Device Regulation MDR 2017/745.
You’ll receive a link for a free template to download to make this exercise easier.
During that video I’ve also created a Quiz to test your knowledge.
The new Medical Device Regulation EU MDR 2017/745 change the definition of a Medical Device.
Now there is more clarity in terms of some additional functions, products.
Bonus: I will also share with you the new products on the scope of the Medical Device Regulation even if they have no Medical Purpose.
Learn about the hard and the soft transition for your Medical Devices within the MDR 2017/745 and IVDR 2017/746. I will show you how you should strategies the transition of your portfolio.
Medical Device Regulation should be implemented for manufacturers that are selling products to Europe. If you are located in Europe or outside of Europe, you’ll have to comply with this regulation.
Medical Device - What means Placing on the market (EU MDR 2017/745)
What is a European Authorized Representative?
Who is the Person Responsible for Regulatory Compliance?
What does it mean to place a product on the market for a Medical Device?
[Download Powerpoint Slides – Link below]
I try to answer this question as it’s not easy to understand the difference when a product is still under the manufacturing control and the product is under the distributor control.
I use the Medical Device Regulation EU MDR 2017/745 and the blue guide as a reference to provide you the answer to it.
Within this video I give you a summary of what is a European Authorized Representative and what is its role and responsibility.
I also answer questions like “Can I change it” or “Should I choose my Distributor”.
I hope this will help you to understand the role of this Economic Operator.
The new EU MDR 2017/745 and IVDR 2017/746 (Article 15) asks now to have a PRRC within your organization.
But what is a PRRC and who can be PRRC? This is what I will answer today with this video.
If you want to have also the article that goes with the video you check it here.
The Replay for my Live Q&A
Is MDSAP made for you?
What is ISO 13485?
I will perform regularly a Live Q&A answering questions I receive from my network.
The list of questions are on the show notes if you want to see them.
I hope you’ll enjoy it.
Don’t forget to subscribe to my Facebook Group to participate to the next Q&A
Within this short video I explain you what is MDSAP.
And I also try to help you to understand if you need this certification.
This depends where you are selling your products and if you are able to respect all the requirements. Enjoy!
ISO 13485:2016 is the most important standard for the Quality Management System of Medical Device companies.
On this Video you´ll learn what it is and who can certify you for it.
Medical Device Industry should really implement this standard as now it´s part of MDSAP and FDA wants to transition to it.
On this video I explain you step-by-step process to find a Notified Body for your CE Marking process.
The NANDO Website is key for that and I will show you my screen and how to navigate inside.
I will provide you clear information on Certificate of Free Sale (CFS) or Free Sale Certificate (FSC) for Medical Devices.
This is a document that you need to prove that your product is CE marked and that it is sold on the country of origin.
Custom-made Medical Devices is really another category of devices. The requirements to put them on the European Union market through the new Medical Device Regulation MDR 2017/745 is really different in comparison to other devices.
On this video, I will provide you all the basic information to understand how to place a custom-made device on the EU market.
After discovering the site Stendard.io, I decided to invite Jason Lim it’s CEO to my podcast and then to test his solution.
My challenge is to create a QMS within 30 minutes with Stendard. This will be a QMS for ISO 13485. I asked Jason to provide me the full access of his software so I can really show you how this is working.
