General
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How to evaluate Benefit-Risk Ratio for Medical Devices?
You maybe arrived to this section of the Techniocal File asking for Risk Benefit Ratio and you don't know what to write on it. On this episode we will explain to you what are your possibilities and how you should thing about Risk-Benefit ratio with Naveen Agarwal.
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How to improve the relationship between QA – RA and Marketing?
Let's see if you can improve relationship between your industry departments and Quality and Regulatory affairs. We will talk about that with Omar M. Khateeb who will explain to us how Marketing and QA RA should work together.
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Medical Device News: January 2023 Regulatory Update
All your Medical Device Regulatory update for January 2023 within 30 minutes. Listen to this podcast episode with Monir El Azzouzi
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Grow your LinkedIn Profile with Karandeep Badwal
If you are looking to grow your LinkedIn profile then you should listen to this episode where Karandeep Badwal will give his learning being part of the LinkedIn Creator Accelerator Program.
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How to choose the best Sterilization Method for Medical Devices?
This is a questions that I get asked when I am part of the design process of medical devices. Which Sterilization method should we choose? I invited Jane Scally to help us define the best practices when it comes to the Sterilization process.
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What do Clients, Followers, Team, … think of Easy Medical Device?
This is the celebration episode for the 200th consecutive week where we released the podcast. This time I asked some of the stakeholders to provide a feedback about their experience with Easy Medical Device and the Podcast.
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Medical Device News: June 2022 Regulatory Update
Medical device news June 2022 is focusing on IVDR 2017/746 date of applciation and consequences. Don't miss all the additional information on guidances, Training,,,
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What to learn about the EU Medical Device situation? [Erik Vollebregt]
Medtech Forum was really a great event with all the Medical Device stakeholders at the same place. Manufacturers, Consultants, Notified Body, European Commission, trade associations, service providers. Let's summarize that with Erik Vollebregt.
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How to prepare an Audit with a Front Room & a Back Room?
Have you ever performed an audit with a Front Room and Back Room? In this episode I will explain to you how this works and what is the interest. This method can help you to have a smooth audit and make your auditor happy.
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Medical Device News – March 2022 Regulatory Update
This month the big news is about FDA amending QSR to integrate ISO 13485. Not sure on how this will be at the end but it's always cool to have harmonization. No worries, other topics like IVDR, MDCG, UK, Saudi Arabia, Spain are mentioned. Enjoy!!!
