State-of-the-art is an important topic, but it is not well understood. That's why I invited Hakan Inan from Requalite to help us gain a better understanding of this concept that you should use in your clinical assessment 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 to the show notes to see the documents that can help you with this.

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Who is Hakan Inan?

Hakan Inan is the founder and director of Requalite GmbH, a medical device compliance consultancy with a special focus on medical writing activities for performance and clinical evaluation reports according to MDR and IVDR. Hakan holds a PhD in nanotechnology and developed in vitro diagnostic devices for cancer applications at Stanford University School of Medicine. Requalite supports 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 scientific fields including immunology, hematology, oncology, neurology and cardiovascular diseases, etc.

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Who is Monir El Azzouzi?

Monir El Azzouzi is a medical device expert, specialized in quality and regulatory matters. He decided to quit his job at the company and found EASY MEDICAL DEVICE. He now supports the medical device industry by educating people with his blog, podcast and YouTube channel and also helping them with advice, coaching and training. He decided to open an office in the UK to support his clients who needed a UK Responsible Person. Easy Medical Device becomes the one-stop shop for the medical device industry.

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Links from the video

Equalite website: www.requalite.com
Linkedin: 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 Guidelines: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-181031-grrp-essential-principles-n47.pdf

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Follow social media

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
Twitter: https://twitter.com/elazzouzim
Pinterest: https://www.pinterest.com/easymedicaldevice
Instagram: https://www.instagram.com/easymedicaldevice

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#EasyMedicalDevice #medicaldevice #regulatorycompliance

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