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
510(k) Submission
510(k) Submission Introduction Radiographic Dental Imagery Device – Class IIb Our client are a leading manufacturer of radiographic dental imaging systems, based in Europe. Following European success, our client set their sights on the US market. Standards & Tools FDA 21 CFR Part 820 GDPR Word Excel, Powerpoint Scope of work Review of documentation for…
Regulatory Strategy IVDR / FDA
Regulatory Strategy IVDR / FDA Introduction Deciphex Deciphex is a digital pathology workflow and integrated AI platform for research pathology, CROs and pharmaceutical companies for handling high volume drug safety pathology studies. They provide a complete GLP-compliant workflow with integrated AI screening capabilities. Standards & Tools Scope of work Brian – Director QA RA As…
Breakthrough Program
Breakthrough Program Introduction IVD manufacturer The company is a highly innovative IVD manufacturer start-up. Their device is CE marked and the client was looking to obtain FDA approval for sale on the US market. Apotech Consultants One consultant worked part-time on the project. The main focus was to design the rationale to be eligible for…