Software as a Medical Device: Beginner’s Guide to Testing & Validation
In this episode, Anindya Mookerjea will share with us his knowledge on Software Testing. We will review the basics and help you with being compliant to your projects. The post Software as a Medical ...
12 Kesä 20250s
Medical Device News JUNE 2025 Regulatory Update
episode 339 Medical Device News JUNE 2025 Regulatory Update monir el azzouzi easy medical device The post Medical Device News JUNE 2025 Regulatory Update appeared first on Medical Device made Easy ...
4 Kesä 20250s
Trapped or Strategic? Changing Notified Bodies During MDR Transition
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 […...
28 Touko 20250s
How deepeye Medical overcame the AI ACT?
In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. The post How deepeye Medical ove...
22 Touko 20250s
Is EHDS dangerous for Medical Device manufacturers?
In this episode, Cecile van der Heijden will disclose all the secret of the EHDS or European Health Data Space law. The post Is EHDS dangerous for Medical Device manufacturers? appeared first on Me...
15 Touko 20250s
When is Regulatory Affairs needed during Design?
In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The post When is Regulatory Affairs needed during Design? appeared first ...
7 Touko 20250s
What is the new UK Post-Market Surveillance Requirements?
In this episode, Claire Dyson will clarify to us what is the new PMS requirements from UK MHRA. The post What is the new UK Post-Market Surveillance Requirements? appeared first on Medical Device ma...
1 Touko 20250s
How to register your Medical Device in Malaysia?
In this episode, Adam Isaacs Rae is helping us to register our Medical Devices in Malaysia. We will review the requirements for it. The post How to register your Medical Device in Malaysia? appeared...
24 Huhti 20250s
