Medical Device made Easy Podcast
Technology
https://youtu.be/QiYehhfxbwg
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:The post Who should be on your Risk Management Dream Team? appeared first on Medical Device made Easy Podcast. hamza benafqir
Summative Evaluation – Common mistakes
Are you more Corrections or Corrective Actions or Preventive Actions?
How to select and evaluate your Contract Manufacturer?
Quality Field Service for Medical Devices
Medical Device NewsMAY 2024 Regulatory Update
Why and how to build a Quality Culture?
What is the impact of AI Act on Medical Devices?
Radiation Sterilisation Master File (ISO 11137 & 11607)
Medical Device News April 2024 Regulatory Update
How to benefit from Surveys to build Clinical Evidence?
How to do Postmarketing Surveillance the right way?
Learn more about FDA QMSR alignment with ISO 13485
Medical Device News March 2024 Regulatory Update
New EU Proposal – EUDAMED, IVDR & Shortage
Will EtO gaz become a Medical Device?
How to get your interview prepared?
Medical Device News february 2024 Regulatory Update
Why you should use Pre-Submission or Q-Sub with FDA?
You are not the Physical Manufacturer, can you be MDR certified?
MEDICA 2023 – InterviewS with Startups, Service Providers, Notified Bodies…
Create your
podcast in
minutes
It is Free
Insight Story: Tech Trends Unpacked
Zero-Shot
Fast Forward by Tomorrow Unlocked: Tech past, tech future
The Unbelivable Truth - Series 1 - 26 including specials and pilot
Lex Fridman Podcast