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
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.
IND vs. NDA: Understanding the Difference in FDA Submissions
For drug developers, FDA approval is a long and complex journey. Two of the most important milestones on this path are the Investigational New Drug (IND) application and the New Drug Application (NDA). While both are critical submissions, they serve very different purposes.