Classification
As specialists in preparing devices for the US market, our team can work with you on the classification of your device to help determine which type of premarket submission you require.
After conducting a detailed analysis of your device, our expert consultants can then align it with FDA guidelines to identify its appropriate class. This is an essential step, not only towards ensuring compliance but also to delivering successful and timely submissions.
Trusted by top-tier teams worldwide
Our GAP analysis services are designed to offer a streamlined pathway to FDA submission success. By conducting thorough assessments of your device documentation and identifying any potential gaps, we can ensure 100% alignment with the FDA’s requirements.
Through this comprehensive analysis, we also provide actionable insights and recommendations to prevent future regulatory issues and optimise your submission strategy.
Featured case studies
Borderline device classification
Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and wellness product manufacturer identified revenue opportunities marketing their cosmetics devices with increase claims. Apotech was engaged to perform a blanket regulatory assessment of cosmetic devices and provide judgement and pathways for market authorisation as a medical device…
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