https://www.pinterest.com/easymedicaldevice

In this episode, Tibor Zechmeister will challenge us on what we would answer if the Notified Body asks if our software is validated. CSV or Computer System Validation will become one of the major topics So stay tuned. 

Who is Tibor Zechmeister? 

Passionate about Creating Maximum Efficiency in MedTech Regulatory | Head of Regulatory and Quality Flinn.ai | Notified Body Auditor | MedTech Entrepreneur | Software Solutions for Regulatory Automation with AI

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link

Tibor Zechmeister LinkedIn:  https://www.linkedin.com/in/tibor-zechmeister/ 

Flinn.ai Website: https://www.flinn.ai/ 

ISO 13485:2016 https://www.iso.org/standard/59752.html 

ISO/TR 80002-2:2017: https://www.iso.org/standard/60044.html 

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