RegNav Resources
RegNav combines expert insights with AI, giving you a detailed picture of your safety and performance requirements.
Refer to our latest resources to learn how you can leverage our solutions for a clear path to compliance
Whitepaper
Medical Devices - Pitfalls and safeguards in robust evidence of safety and performance for regulatory submissions
Author: Nicole Small, Michael Kipping and James Pink
Whitepaper
Accelerate your medical device’s route to market: Consider the regulatory pathway early on
Authors: Michael Kipping and James Pink
Start your journey
Whatever stage you’re at, RegNav can support
We support Medical Devices across all classes (Class I, II & III)
All pathways for FDA clearance and approval are covered
We support CE marking across a range of device types
RegNav Premium
A full compliance plan, product classification and timeline.
Whether you are pre or post design lock, we can identify the standards that are applicable to your device.
You will receive a full outline of the regulations and standards that are likely to be required for your product.
Our AI assists with determining the most efficient testing pathway for you.
Your case will be fully overseen by leading compliance experts
RegNav Verify
Expert validation of an existing compliance plan.
Use the tool for a free assessment of your compliance plan to assist with determining if you have found all applicable standards.
Making a design change? We can tell you how that will change your compliance plan.
Your case will be fully overseen by leading compliance experts