The future of medical device compliance: intelligent, automated, reliable.
RegNav combines expert insights with AI, giving you a complete picture of your safety and performance requirements. Save time, reduce stress, and focus on bringing your innovation to market.
25% less expensive than traditional methods
Fast delivery - get your plan in as little as 2 weeks
AI-powered efficiency, fully reviewed by experts
Developing a medical device is thrilling, but navigating regulations can be daunting.
RegNav bridges that gap. Our AI and expert guidance tool creates a product specific roadmap for you, streamlining the journey through clearance or approval.
2,432
US regulations applicable to medical devices
136
Potential characteristics defined for medical devices
50,000
510K summary documents
850
Standards
Step One
We learn about your product and target market
Step Two
We identify the relevant regulations and standards
Step Three
We guide you through your compliance requirements
Step Four
We create your product-specific compliance plan
Ongoing innovation, built on history
For 200 years, Element has ensured the safety and integrity of countless critical products. Leveraging Element’s global expertise and trusted reputation, RegNav guides you seamlessly through compliance, accelerating your path to market. Don't just trust technology, trust the integrity, care and progress that defines Element.
‘Medical Devices - Pitfalls and safeguards in robust evidence of safety and performance for regulatory submissions’
Download a free copy of our whitepaper, authored by our medical compliance consultants Nicole Small, 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 required regulations and standards required for your product.
Our AI tools ensure you have the most efficient testing pathway
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 see 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