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

  • "I didn’t really understand the scale of what is needed [to go down the regulatory pathway]. Going through the questions you have to answer really helps break down what you need to think about. Having the compliance strategy really puts things in context."

    Joseph Hawkins, Director of Operations, SleepCogni

  • “If I had access to this in the early days it could have saved me months of time”

    James R – Startup CEO & Founder

  • "Time is money and additional trips back to the FDA has a real cost - a solution like this one would really allow us to make sure we comply with all standards and requirements, and apply for approval with much higher confidence"

    Narinda S - Lead Compliance Officer

  • "It is a great guidance tool, especially for startups and SMEs that need to bring products to the market rapidly, this would allow us to save tons!"

    Jennifer G - Chief Financial Officer

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