The future of medical device compliance: intelligent, automated, reliable.
RegNav combines expert insights with AI, giving you a detailed picture of your medical device’s 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 EU or US plan in as little as 2 weeks
AI-powered efficiency, fully reviewed by experts
FDA Product Code Finder
Try our new complimentary FDA product code finder to find matching product codes for your medical device.
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 towards 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 towards market. Don't just trust technology, trust the integrity, care and progress that defines Element.
View RegNav Resources
See all of our industry-expert-authored whitepapers to aid you through your regulatory journey.
Start your journey
Whatever stage you’re at, RegNav can support
We support medical devices across all risk classifications
We support all pathways
We support US, UK/EU and other jurisdictions that use IMDRF
Verify
Expert validation of an existing compliance plan:
Easy to use tool that ensures you’ve identified all applicable standards for your project.
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.
Premium
A full compliance plan, product classification and timeline:
Whether you are pre or post design freeze, we can identify the standards that are applicable to your device.
You will receive a full outline of the regulations and standards that are required for your medical device.
Your case will be fully overseen by leading compliance experts.
Premium Plus
Everything in Premium, plus product-level requirements:
Receive a detailed list of requirements your device needs to adhere to for enhanced planning and decision making.
Understand verification method for each requirement to ensure compliance.
Your case will be fully overseen by leading compliance experts to ensure thoroughness and alignment with industry standards.