Company Stage: Developing digital health product (SaMD)
CHALLENGES
Client staff consisted of physicians and engineers who had no experience with medical devices and regulations
Aggressive timeline for software development, testing, and FDA submission
No quality system and no head of quality
SOLUTION
Used a staged implementation for quality system procedures and compliance. Started with simplified procedures for software change control, risk management, and requirements management. Added formal controls and documentation as the project progressed.
Created a core set of SOPs to govern product development: Risk Management, Design Controls, Cybersecurity, Document Control, and Non-Product Software Validation (CSV)
Helped client select and implement a requirements management tool (ALM system) and use it for requirements, risk analysis, and testing
Assisted product team in writing and releasing new software and cybersecurity documentation
RESULTS
Client had a Design History File and Risk Management File established early in development with documented milestones
The team learned how to follow the new design control processes as they were implemented
When a Head of Quality was hired six months later, he was able to quickly get started and build on the processes and DHF documentation already established
