Medical devices

In a time of unprecedented rapidity of change in the healthcare sector, innovative medical devices and products improve and save lives. However, new medical devices face a long and expensive route to market in a complex and changing regulatory environment.

Engaging consultants to identify the right regulatory pathways and prepare regulatory documentation for each market can cost hundreds of thousands of pounds.

The Health Care Regulatory Explorer lets you harness the power of Regtik to explore and understand the regulatory pathways for your health care product at a fraction of the cost. You can reduce time-to-market by ensuring regulatory compliance is part of your business practice from day one. We will help you to select the most appropriate strategy for you to manage quality, compliance, regulatory requirements, and innovation.

From concept to launch - Regtik provides regulatory support all the way through your development pipeline. Our easy-to-use platform combines the knowledge of world-leading regulatory experts with our patent-pending compliance expert system:

  • Get insight into the regulatory landscape and potential pathways to market for your product

  • Rapidly revise product concepts and re-assess product changes as often as you like at no extra cost, enabling rapid innovation cycles for digital therapeutics and software-as-a-medical device (SaMD)

  • Accelerate towards product launch by developing a regulatory strategy for licensing and launch across the key global markets: United Kingdom, European Union, USA and Australia

  • Increase investor confidence and funding round participation by de-risking regulatory compliance and creating an audit trail to demonstrate compliance with legislation, regulations and standards

Regtik stays ahead of regulations - we scan the skies, allowing you to focus on development and innovation.

Using our guided assessment system, you'll find out your product's qualification and classification under the medical device regulations in minutes. You will then be shown the available regulatory pathways and get step-by-step requirements for those pathways.

You can also explore ways to influence the classification of your device to find faster paths to market.

Our expert team will set up a call to review your assessment and brainstorm a regulatory strategy. They'll also send you a formal report setting out the full justification of the qualification, classification, and available pathways ready to include in your regulatory submissions.

HELPING fight dementia

“The Regtik report that we received is outstanding. It's been instrumental in planning our route to market, and we frequently refer to it in conversations with funders, research collaborators, and health and social care providers.”

Zeke Steer, CEO, Milbotix