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medical device compliance

know how to navigate the complex process of regulatory approval

Online Medical Consultant

regulatory strategy

Regulatory compliance for a medical device is the most important part of the process and it should start at the beginning of the project. Start-up companies leaving it too late will incur unnecessary costs and may fail to launch the product to the market. Moreover, if you place non-compliant medical devices on the market this could lead to unlimited fines and prison sentences. 

This service is intended for anyone who wants to bring a medical device of any risk level classification to market, whether it is in the pre-prototype or prototype stage.

we will work to:

  • Reduce your project’s technical risk

  • Reduce regulatory cost and uncertainty

  • Highlight gaps in your proposal preventing any unnecessary additional costs and delays to launch the product to the market

this process will:

  • Identify and assesses any risks to start mitigation planning

  • Support in the regulatory strategy analysis, claims, device classification and road map

  • Assess any gaps, risks, additional costs and actions to mitigate against medical device regulations to assure compliance

get in touch and start your journey with thrive
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