Integrity, A PTC Product (formerly MKS Integrity) enables organizations to reduce the overwhelming complexity of developing software intensive products for the Medical Device Industry thereby removing barriers to rapid innovation.
Integrity manages all software system development processes and connects all software engineering artifacts, including requirements, models, code and test, ensuring comprehensive lifecycle traceability. The traceability in Integrity ensures complete coverage of risk with measurable controls and satisfies key regulatory reporting requirements of FDA CFR 21 Part 820 and the European MDD.
With the emergence of software driven innovation, this phenomenon has produced complexity that puts pressure on medical device manufacturers’ current state processes and technologies which disconnected tools and processes cannot handle.
Medical Device Industry Solution Components include:
- Integrated Risk Management
- Requirements Management
- Verification and Validation
- Software Configuration Management
The implications of not solving these problems include:
- Lack of visibility to release readiness
- Risk of costly, non-compliant processes
- Product quality suffers, leading to increased cost and negative brand impact
A totally unique product for medical device companies looking to improve their competitiveness in the market, Integrity offers organizations:
- Engineering artifact orchestration
- Complete ecosystem integration
- True enterprise wide value