Why Risk Management is important to Medical Device development?
Risk Management is a discipline of its own within the Medical Device field. In ISO 13485, EU MDR 2017/745, IVDR 2017/746, FDA QSR, MDSAP… All of them talk about Risk Management. You should manage your risks. But why is this so important or even critical? This is what we will discuss with Kailash Kalidoss who is a Medical Device Engineer and also a NASA Ambassador. He will share with us his experience.
PS: if your company needs an EU, UK or Swiss Authorized representative or Importer, don’t hesitate to contact Easy Medical Device. See the link below.
Who is Kailash Kalidoss?
The foundation of my professional experience is in consulting for complex MedTech projects, from conceptualization to product release. In my 13+ years of experience, I have worked as a Design control consultant for various leading US-based Medical Device Companies. I’m also certified by AAMI for Medical Quality System Regulations. Currently, I work for a cutting-edge engineering consulting firm based out of the Bay area in California. Academically my career is well rounded with an MBA from a prestigious B-School. Also, I have good exposure to STEM fields through MS and Engineering Bachelor degrees earlier, to effectively complement the B-School erudition. SPECIALITIES: Medical Device Design Control, Verification, and Validation, Software in Medical Devices and SaMD, Quality, Medical Device Regulations BEYOND WORK: Aerospace Educator for Civil Air Patrol, a United States Airforce Auxiliary. NASA Solar System Ambassador.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
- Kailash Kalidoss LinkedIn: https://www.linkedin.com/in/kailashkalidoss
- iso 14971:2019. https://www.iso.org/standard/72704.html
- EU MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1589797311848&uri=CELEX:02017R0745-20200424
- Authorized Representative and Importer for EU, UK, and Switzerland: https://easymedicaldevice.com/authorised-representative-and-importer/
- eQMS SmartEye: https://scube-technologies.com/why-s-cube/
3 Replies to “Why Risk Management is important to Medical Device development?”
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Does not 21 CFR for US products and MDR require risk compliance per ISO14971?
Yes ISO 14971 is an harmonized standard in EU MDR but in the US this is not clearly mentioned. But a standard is voluntary so you can decide to use it and I advice you to use it
I would take care with some of the items mentioned such as ALARP and use of FMEA. While these may be acceptable in the US, expectations in the EU may need to follow MDR requirements which are different to those mentioned.