Financial Implications of Notified Body Certification

If you are looking for selling your medical devices in Europe, you will then maybe need a Notified Body unless your product is class I. In this episode, we talk with Thomas Lommatzsch about the process of designation and why it is so difficult. We will also cover some questions regarding the auditors, the costs, the audit by the competent authorities… So stay tuned.
► Who is Thomas Lommatzsch?
Thomas LOMMATZSCH heads the Medical Business Unit of AFNOR Certification, which deals with the certification of medical devices within the notified body AFNOR Certification (NB0333). With over 20 years' experience within Notified Bodies under various European regulations, he has completed several notification projects, most recently the AFNOR Certification notification project under the MDR. Thomas is also involved in standardization work relating to the application of the AI Act, particularly with its application to medical devices.
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► Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
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► Links from the Video
■ Thomas Lommatzsch Linkedin Profile: / thomas-lommatzsch
■ AFNOR webpage: certification.afnor.org/quali...
■ EU MDR 2017/745: eur-lex.europa.eu/legal-conte...
■ EU IVDR 2017/746: eur-lex.europa.eu/legal-conte...
■ French competent authority ANSM: ansm.sante.fr/
■ JAT Joint Assessment: health.ec.europa.eu/document/...
MDCG 2022-13 Designation, re-assessment and notification of conformity assessment
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► Social Media to follow
■ Monir El Azzouzi Linkedin: / melazzouzi
■ Twitter: / elazzouzim
■ Pinterest: / easymedicaldevice
■ Instagram: / easymedicaldevice
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#easymedicaldevice #medicaldevice #regulatorycompliance

[@EasyMedicalDevice]

For full episode check:ua-cam.com/video/D3FuAAhEr7Q/v-deo.html