How to write your Performance Evaluation? [IVDR 2017/746]
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In this episode I have invited Hakan Inan from Requalite to help us understand the situation for In-Vitro Diagnostic device manufacturers and also on how to create a Performance Evaluation Report.
In this episode Hakan will provide you all the elements so that you have a good understanding of the Performance Evaluation process. This will include also so comparison to the EU MDR legislation and define if there are some commonality.
The IVDR industry should start urgently its transition to the EU IVDR 2017/746 and most importantly we will need more Notified Bodies to help these companies to get certified.
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 quite 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.
Links
- Requalite Website: www.requalite.com
- Linkedin: https://www.linkedin.com/in/hakaninan
- Linkedinpage: https://www.linkedin.com/company/requalite-gmbh
- Document Links for PER:
- http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n6-2012-clinical-evidence-ivd-medical-devices-121102.pdf
- http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n7-2012-scientific-validity-determination-evaluation-121102.pdf
- http://www.imdrf.org/docs/ghtf/final/sg5/technical-docs/ghtf-sg5-n8-2012-clinical-performance-studies-ivd-medical-devices-121102.pdf
- https://www.medtecheurope.org/wp-content/uploads/2020/05/MedTech-Europe-Clinical-Evidence-Requirements-for-CE-certification-eBook-2020.pdf
The post How to write your Performance Evaluation? [IVDR 2017/746] appeared first on Medical Device made Easy Podcast.
