How it works
Navigate medical device regulation and compliance with confidence: RegNav smooths your journey towards market launch.
Faster to market
Design for safety
Investor-ready planning
Clear regulatory path
Integrate regulatory considerations into your design process from the beginning.
Get your device to market quicker with our efficient process.
Understand how the regulatory authorities view your device and likely steps needed for approval.
Provide investors and funding bodies with clearer timelines and competency.
Identifying your route to market
The medical device industry has a well-defined regulatory framework. To bring a device to market, manufacturers must follow specific pathways determined by the device's risk classification. A thorough understanding of the applicable regulatory process is crucial for an efficient and successful market launch.
Early misclassification can lead to a domino effect of delays, restrictions, and potentially reduced competitiveness in the market.
RegNav tackles this challenge with AI features that process product descriptions and characteristics, allowing for swift and confident classification and a clear understanding of your route towards market.
Understand the regulations and requirements
Knowledge of market-specific regulations and product-specific requirements that impact safety, performance, and equivalence is essential for efficient planning of the evidence gathering stage.
Overlooking regulations means delays (market access), extra costs (fixing issues), and potential penalties. This can damage your reputation with regulatory bodies and cause financial setbacks.
RegNav simplifies this process by working with you to define your product's purpose, use, and characteristics. We help pinpoint regulations, standards, and requirements you are likely to need to meet for compliance.
Planning to address and fulfil the correct requirements
Interpreting the full scope of regulatory requirements, technical standards, and other key specifications can be challenging and requires significant expertise and experience.
Medical device regulations can be misinterpreted or overlooked, potentially causing application rejections, safety concerns, development delays, and even unsafe products reaching patients due to inadequate planning.
RegNav provides a comprehensive and reliable compliance plan for your device from the wide array of medical device regulations and standards. RegNav gives you increased confidence that you’re testing the right thing using the right methodology.
Generating and managing your evidence
Selecting the most appropriate verification methods and partners is crucial. Manufacturers need clarity on the purpose, timing, and execution of verification activities, along with identifying qualified partners for reliable evidence generation.
RegNav provides a compliance plan that can be used as a reference point for all your testing.
Our global network of Element labs and trusted partners are there to advise on the correct methods of demonstrating compliance and ensuring that those methods are suitable for the conditions outlined.
270 laboratories. With over 9,000 Engaged Experts in over 270 facilities in the Americas, Europe, Middle East, Africa and Asia, we are the ‘go-to team’ for all of your testing, inspection, certification and calibration needs.
Try our complimentary product code finder. It’s as easy as a simple search!
Enter your search terms below to get started. You can use descriptive language or search for a specific product code if you know it.
Step One
We learn about your product and target market
Enter details about your product, including its features and functionalities.
Specify the market you intend to sell your product in.
We’ll provide you with a report detailing the product characteristics, the specific classification and route towards your chosen market.
Step Two
We identify the relevant regulations and standards
Based on your product information and initial assessment, RegNav identifies relevant regulations, standards, and similar products.
RegNav refines your product information to help determine that it meets the criteria for specific regulations and avoids those that don't apply.
We’ll help you find your predicate and understand the predicate chain relevant to your 510k device.
Step Three
We guide you through your compliance requirements
With a clearer picture of applicable regulations and standards, RegNav provides a list of essential principles you need to address.
We identify if any compliance certification you already possess is applicable for your product.
Step Four
We create your product-specific compliance plan
Your compliance strategy can help you understand the impact on your product strategy, development plan, and resources.
You can estimate costs, timelines, and any adjustments needed for compliance.
We can connect you with our Element testing labs and trusted partners globally.
