The Omnicon Group establishes a clear and well-defined strategy to help our customers evaluate what they have in terms of documentation and what additional documents or artifacts they will need to prepare and submit the Premarket Approval Application to the FDA. Our engineers have been involved in the development, regulatory clearance, and commercialization of multiple medical systems currently being sold throughout the United States. It is this extensive experience in FDA PMA Services that makes us the supplier of choice for our customers.
Omnicon continues to assist multiple companies in obtaining FDA premarket approval for safety-critical and revenue-critical medical devices. We develop, upgrade, and validate software for FDA approval, and we have customized FDA premarket application packages for existing devices.
FDA Premarket Approval Applications (PMA)
Per 21 CFR Part 814, FDA premarket applications require a detailed documentation package proving the pedigree of software resident on medical devices. Omnicon has experience in leading devices through FDA (Class I, II and III) approval and clearance. A well prepared package will make the approval process smooth and reduce time to market for competitive devices.
- Level of Concern Determination
- Quality Systems
- Device Hazard Analysis
- Requirements Specification
- Architecture Design Chart
- Design Specification
- Traceability Analysis
- Development Environment Description
- Verification and Validation Documentation
- Revision Level History
- Unresolved Anomalies
Product Lifecycle Development
The software on a medical device is only as good as the software development processes that produce it. Omnicon continues to perform safety-critical software development in multiple arenas and has an extensive history of safety-critical software in industries that require certification and approvals from authorities, including medical devices.
- Quality Planning
- System Requirements Definition
- Detailed Requirements
- Operation and Support
Jennifer Millard July 18, 2016