How to build your State-of-the-art for your Medical Devices?
State-of-the Art is an important topic but not well understood. It’s why I have invited Hakan Inan from Requalite to help us get a better understanding of this concept that you should use on your Clinical Evaluation or Performance Evaluation. We will talk not only about MDR but also about IVDR as this concept is required for both. Don’t hesitate to go on the show notes to see the documents that can help you with that.
Who is Hakan Inan?
Hakan Inan is the founder and the managing director of Requalite GmbH, Medical device compliance consulting company, with a special focus on Medical writing activities for Performance and clinical evaluation reports as per MDR and IVDR. Hakan holds a PhD in Nanotechnology and has developed in vitro diagnostic devices for cancer applications at Medicine Faculty-Stanford University. Requalite provides support to Medical device and In vitro diagnostic device companies in their compliance journey by designing and creating Performance and Clinical Evaluation Reports. Requalite has a strong team of experts, all with PhD degrees in the scientific fields including immunology, hematology, oncology, neurology, and cardiovascular diseases, etc.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert Specialised in Quality and Regulatory Affairs. He decided to quit his corporate job to start EASY MEDICAL DEVICE. He is now providing support to the Medical Device industry by educating people with his Blog, Podcast, Youtube channel and also helping them through consulting, coaching, and training. He decided to open an office in the UK to be able to support his customers that would need a UK Responsible Person. Easy Medical Device is becoming the one-stop-shop for Medical Device Industry.
- Requalite Website: www.requalite.com
- Linkedin profile: https://www.linkedin.com/in/hakaninan
- Linkedin page: https://www.linkedin.com/company/requalite-gmbh
- MDCG 2021-5: https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_5_en.pdf
- IMDRF guidance: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-181031-grrp-essential-principles-n47.pdf
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