Understand IEC 62304 for Medical Device Software with Adnan Ashfaq
If you are developing Medical Device software then IEC 62304 is an important standard for you. In this episode, Monir El Azzouzi invited Adnan Ashfaq from Pharmi Med Ltd to explain to us what is this standard.
He will also mention some key links to the EU MDR 2017/745 and to other standards. Here are some of the questions asked:
- Which medical device companies should use IEC 62304?
- Do I need to be a Software developer to be able to work on IEC 62304?
- What is the difference between software classification provided by IEC 62304 and EU MDR 2017/745?
Adnan is offering also a document to download which will help you during your projects with this standard.
Who is Adnan Ashfaq?
Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in Medical Device, Biotech, and Pharmaceutical industries.
Adnan founded Pharmi Med in 2011 and has since been supporting Medical device companies around the labyrinth of regulations and assisting them in flying through successful audits.
He has been working with start-up companies and multinationals in developing new products since 1999. With regulations tightening up, especially in Europe, Pharmi Med is enabling and trying to help simplify the compliance conundrum to ensure manufacturers reach their desired market and stay in the market.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.
After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links
- Adnan Ashfaq Linkedin: https://www.linkedin.com/in/adnan-ashfaq-44478121/
- Pharmi-Med Ltd: https://www.pharmi-med.com/
- SaMD audit template: https://mailchi.mp/easymedicaldevice/iec62304
- MDCG 2019-11: https://ec.europa.eu/docsroom/documents/37581
- IMDRF guidance on SaMD: http://www.imdrf.org/workitems/wi-samd.asp
- IEC 62304 standard (affiliate): https://tidd.ly/2Bfjz4a
- Episode 81- Process Validation with Adnan Ashfaq: https://podcast.easymedicaldevice.com/81/
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