Development Model
Our development model starts with your program requirements and follows specific tasks designed to minimize program risk and maximize output. With this model we can work independently or in tandem with client teams.
Our spiral design process utilizes a spiral model providing multiple prototype releases throughout the development cycle. This allows for early verification of product performance and allows identification of specification changes, user interface performance and hazard controls early in the process.
FDA regulatory compliant
Waterfall or spiral (e.g. Agile)
Designed for Class l, ll and III medical devices
Meets FDA 21 CFR 820.3 and 21 CFR 820.30 requirements
Risk analysis process is compliant with EN 60601 standards
Fault Tree / FMEAC analysis
Traceability and DHF intensive
ISO 13485 certified through TUV
Customized to the life-cycle requirements of the program, e.g. EN 63204
Case Studies
