Case Study: CVRx achieves faster time-to-market and improved risk management with PTC Integrity (PTC)

CVRx ® manages risk and accelerates time-to-market with PTC integrity

CVRx, a privately held medical device company developing the XR-1 baroreflex activation therapy system, faced the challenge of accelerating time-to-market for a Class III implantable device while meeting stringent FDA and EU design-control and documentation requirements. After about a year on IBM Rational DOORS, CVRx needed a more flexible, integrated platform to manage requirements, specifications, tests, change requests, defects and traceability — so they turned to PTC and its PTC Integrity solution.

PTC implemented a single, end-to-end engineering documentation and development platform (PTC Integrity) that grew to include requirements, source code management, risk and quality processes, and automated regulatory reporting. Using PTC Integrity CVRx achieved full traceability from risks to mitigations to requirements, source code and verification tests, enabled RPN tracking and automated DHF generation without extra staff, shortened iterative cycles to six months, improved audit responsiveness, reduced implementation and maintenance costs, and supported the first XR-1 built end-to-end with PTC Integrity being implanted.

CVRx