medical device documentation requirements
Industries We Serve:
Combination Products
Here’s How We Can Help
Whether you’re entering the market as a wearable delivery device or converting your vial into a pre-filled syringe, combination device documentation requirements are rigorous. We’re here to help tackle your:
- Essential performance requirements
- Human factors study documentation
- Product control strategies
- Design control matrices
- Device & design history files
Delivering Regulatory Services that Make a Real Difference.
Regulatory Writing
Consulting Services
Additional Services
GLOBAL Resources
Proposed Changes to EU MDR: What Manufacturers Need to Know
The European Commission has proposed a series of updates to the EU Medical Device Regulation (MDR) aimed at improving efficiency, reducing burden, and addressing long-standing bottlenecks—particularly around Notified Body capacity, classification clarity, and clinical requirements.
What is IVDR?
The In Vitro Diagnostic Regulation (IVDR) (EU 2017/746) is the European Union’s regulatory framework governing in vitro diagnostic medical devices—tests and instruments used to examine human samples like blood or tissue. For manufacturers, understanding the IVDR is essential for maintaining or gaining access to the EU market.