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