CE Marking in EU MDR Explained | Medical Device CE Certification Requirements | Dr. Ashish Jha

Описание: About Video:
Learn everything you need to know about CE Marking under the EU MDR (European Union Medical Device Regulation). In this video, we break down the CE certification process, the essential requirements, and Notified Body involvement for medical devices. Understand how to prepare your technical documentation, conduct a clinical evaluation, and navigate the conformity assessment route effectively.
✅ Key Topics Covered:
What is CE Marking under EU MDR 2017/745?
Steps for CE Certification for Medical Devices
Role of Notified Bodies & Manufacturer Obligations
Risk Classification and GSPR
Common Pitfalls to Avoid
Whether you're a Regulatory Affairs professional, Medical Device Manufacturer, or a QA/RA beginner, this video will help you stay compliant with the latest European regulatory standards.
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About Dr. Ashish Jha:
Dr. Ashish Jha is a Ph.D. graduate in Nano & Bio Technology from IIT-Bombay, specializing in nano formulation development, in-vitro & in-vivo characterization, and cancer therapy. His research focuses on developing plasmonic nanoparticles for photothermal therapy in breast cancer. He aims to apply his academic and industrial expertise to solve critical challenges in the field of nanotechnology and biotechnology.

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