"Reverse" FDA Compliance
Retroactive development of approval documents
apartis produced the FDA-approval documentation in accordance with 510(k) and 21CFR, part 11 for medical equipment software that had been developed previously. This enabled the manufacturer to launch their hardware and software on the American market.
apartis services:
- Adaptation of the software to FDA guidelines
- Documentation of all functional requirements („Software Requirement Specifications“ SRS)
- Detailed design with workflows and use cases
- Linking of every step for full traceability
- Risk analysis of product, software architecture and implementation
- Validation: test plans, extensive test execution, clinical studies