Premarket Approval (PMA) Submissions
For high-risk (Class III) medical devices, a Premarket Approval (PMA) is the most rigorous FDA pathway.
We offer complete PMA support including:
- Pre-submission consultation: Engage early with FDA to address key questions
- PMA compilation: Complete and organise all required modules
- Preclinical testing: Manage testing strategy and execution
- Clinical investigation support: From design to data interpretation
- Advisory panel preparation: Prepare materials and provide representation
- Annual reporting: Fulfil all post-market PMA compliance needs
- PMA Supplements: Submit updates for design, manufacturing, or labelling changes
Trusted by top-tier teams worldwide
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…