Requirements
cGMPs Medical Software and Production Environment(s)
Compliance with current Good Manufacturing Practice regulations for medical software and the production environments on which it operates
Essential Technical Experiments Results
A description of the target performance specifications/goals and experimental results that demonstrate that the technology is capable of meeting/beating the desired performance levels
Interoperability Validation
Validation of the interoperability of the software across target platforms
IP search report
A search report is a report established by a patent office which identifies documents which may be taken into consideration in deciding whether the invention to which a patent application relates is patentable over the prior art.
Key In-Sourcing Requirements Committed
All key items (data, parts, code, infrastructure, etc.) that are being provided by external organizations are committed with at least a MoU
Works-Like-Looks-Like prototypes
Prototypes that work like and look like the intended product that are built under controlled conditions and can be used in testing.