Classification Medical Device in EU (Medical Device Regulation MDR 2017/745)
ฝัง
- เผยแพร่เมื่อ 2 มิ.ย. 2024
- Medical Device Regulation Training - 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.
This step is important for the Medical Device Industry.
I'll tell you How many classes it exists, why this is important. I'll also inform you about all the rules that exist and in the end, you'll have some exercises to test your knowledge.
I will also provide you with a free form to download so you can be more efficient when you'll have to classify your product. Look at the notes below for the link
************************** Links *************************
- Participate to the free Mini-Course on MDR 2017/745 (6 days challenge)
easymedicaldevice.com/mdr
- Free Form to classify your medical device
easymedicaldevice.com/class
- Article on Medical Device Classification in Europe
easymedicaldevice.com/mdclass
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Monir El Azzouzi
Easy Medical Device
#medicaldevice #medtech #regulation
This is my first video and I really enjoyed doing it. I hope this was valuable to you. I really want Easy Medical Device to provide value to the Medical Device Industry community. Let me know if this helped you by commenting on this video.
I subscribed. I’m looking forward to more videos from your channel.
Cheers!
I like this Model, but for some of those rules we really need an interpretation.
I´m for example stuck with Rule 11 for medical software. Ie rule 11 clear for everybody?
Are you confident with this picture?
www.bing.com/images/search?view=detailV2&ccid=CKRqjs%2Fp&id=D2116ACCC3D918A0EEA97C26BD9787A5132C1B87&thid=OIP.CKRqjs_pcWcnrNw2vYbitgHaFj&mediaurl=http%3A%2F%2Fwww.pepperlaw.com%2Fresources%2Fjpg%2FCA_110916_Privacy_SummaryChartImage_web.jpg&exph=1800&expw=2401&q=software+as+medical+device+2016&simid=608012160472252851&selectedindex=26&ajaxhist=0&vt=0
Thanks it's really very useful for me. Iam really impressed. Can you please provide me your contact information.
Dr. Virensinh Zala
Thank you professor, it's really very helpful.
Easy Medical Device hi , I want to import surgical instruments from Pakistan in UK , do I need CE mark from UK or I can import it simply with self CE mark
Man you're a work horse. You just made something boring very easy. Thank you very much for your effort !
Très simple et très bien expliqué
Bravo Monir 👏🏻👍🏻
You've picked a very narrow nieche on this topic my man! :D Great stuff, thank you!
Very well and in simplified manner explained.
This is very nice and excellent presentation
Very helpful video, thank you...
Do you have the same for IVDR
Very helpful. Great job!
Hello sir, excellent video. How do you pick the rules? Sometimes rule #8, sometimes rule #2 etc? How do I know which rule takes precedense?
this was really useful! thanks :)
Very well Explained Sir :)
Hi sir can you share more details or complete elaboration on information related to assessment procedures
Defined well
Good bro
What would be the Class for HOSPITAL BED WITH PANEL ?
CLASS I?
Thnaks