Medical Device Blog

Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing

Soledad

New Draft Compromise Amendments for AI in the EU

A new Draft Compromise Amendments for AI in the EU has been published and you can download it below. Also, AF Pharma can help you.

Soledad

MHRA Updated Guidance on Software: Understanding Medical Device Status and Regulation

In the ever-evolving field of medical devices, software applications (apps) are playing an increasingly significant role. To ensure the...

UPDATED GUIDANCE MHRA

This guidance document replaces the previous MHRA guidance titled “medical device standalone software, including apps”.