If you are selling a Medical Device that is not a class I, then you know that you have to go through an audit with a Notified Body. So let’s discuss how you should be prepared for that with Karandeep Badwal. 

An Audit is really an exercise that all Quality and Regulatory people should understand to master it. See it as a performance on stage, or a sport competition. Before it happens, you should prepare yourself. We will discuss on this episode with Karandeep Badwal of the way that you should be preparing and the tips and tricks that you will need to know. Internal audit, CE audi, ISO audit, MDSAP audit, Supplier audit … You’ll have to go through this within many occasions so be ready for it.

Who is Karandeep Badwal?

Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical.

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.

Links from the Video

Karandeep Badwal LinkedIn Profil: https://www.linkedin.com/in/karandeepbadwal/

Easy Medical Device blog on audit: https://easymedicaldevice.com/internal-audit/

Podcast episode on audit: https://podcast.easymedicaldevice.com/175/

Video on internal audit: https://www.youtube.com/watch?v=UA_J_WXLPag&pp=ygUiZWFzeSBtZWRpY2FsIGRldmljZSBpbnRlcm5hbCBhdWRpdA%3D%3D

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

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