When you look at ISO 13485 or EU MDR or US FDA, they all want to see that you are reducing the risk for your products. But to do that you have to brainstorm and identify those risks. Usually, we follow ISO 14971 for that. But not all of your team is aware of this, and we are now short on time. So, what to do? Draft it by yourself or work with some colleagues. Naveen Agarwal will be sharing with us the best way to collaborate to create a successful Risk Management process. So, let’s listen to that. 

Who is Naveen Agarwal? 

Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family. 

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: 

Naveen Agarwal Linkedin : https://www.linkedin.com/in/naveenagarwal/

Linkedin Post: https://naveenagarwalphd.substack.com/p/collaboration-is-the-secret-sauce-for-riskmgmt 

Achieve Website: https://www.achievexl.com 

Let Us Talk Risk Newsletter: https://naveenagarwalphd.substack.com/ 

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

Authorized Representative and Importer services: https://easymedicaldevice.com/authorised-representative-and-importer/

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