Mehryar Behizad
Currently the Regulatory Director at Endomagnetics, Mehryar Behizad has worked in regulatory affairs with high technology medical device and biopharmaceutical industries as a TOPRA member for more than 25 years.
JournalMedical device standards update: November 2023
This edition of our regular column updates the progress of applicable standards to October 2023.
JournalMedical device standards update: June 2023
This edition of our regular column updates the progress of applicable standards to March 2023.
JournalIMDRF: Origins, purpose and current work
In a landscape of rapidly evolving technologies, the International Medical Device Regulatory Forum (IMDRF) aims to accelerate international medical device harmonisation. A summary of the work being undertaken by the IMDRF.
Meeting ReportMD2: How to approach Artificial Intelligence
and Cybersecurity now and in the futureCybersecurity is important for medical devices – those designed before the era of cybersecurity are most vulnerable to malware attacks and industry are searching for solutions.
![[FROM LEFT] Alwin van den Broek and Walter van Der Weegan](https://ds982gbwnvyso.cloudfront.net/Pictures/100x67/4/3/0/430_5m4a4635_toprasymposium2022_day3_20221019_77249.jpg)
Meeting ReportMD3: Clinical investigation from
a virtual setting perspectiveThere is a variety of devices currently used to collect PROs and the data gathered in relation to orthopaedic surgery. The forthcoming AI, cyber resilience, data governance, and digital market acts are proposed as the regulatory landscape of the future.
Meeting ReportMD5: How to maintain your medical device
on the market and fulfil ongoing obligations
in the post-launch phaseEUDAMED is an integral part of the MDR and the actors, UDI and certificate modules are now live. The full effect of EUDAMED will not be realised until it is fully functional – all actors should accelerate their preparation for EUDAMED and upload information as soon as modules go live.
JournalMedical device standards update: September 2022
This edition of our regular column updates the progress of applicable standards to September 2022
JournalMedical device standards update: February 2022
This edition of our regular column updates the progress of applicable horizontal standards to February 2022
Meeting ReportMD4: Clinical investigations – Is coordinated CA assessment the future?
The first speaker was Amy Bennet, who highlighted that any coordinated clinical assessment requires sound data gathered from preclinical development, especially in class IIa, IIb and above devices.
Meeting ReportMD2: Global development strategy, which market should you go to first?
Michelle Lotte started the session. She summarised considerations of the MDD/MDR transition against submission to the FDA.
Meeting ReportMD1: MDR implementation – is there a future for legacy devices?
The first speaker for this session was Derek Foit. He defined legacy devices per Article 120 MDR, provided examples of class I to class III devices including nanoparticles, nasal sprays as specific cases…