medical device compliance
know how to navigate the complex process of regulatory approval
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