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

CVRx Manages Risk and Accelerates Time-to-Market with Integrity

CVRx, a Minneapolis-based medical device company developing the XR-1 Baroreflex Activation Therapy system, faced the challenge of meeting stringent Class III regulatory requirements while accelerating time-to-market. After a year using IBM Rational DOORS, CVRx needed a more flexible, integrated engineering platform to manage requirements, specifications, tests, change control, and traceability for Design History Files and regulatory reporting — so they selected PTC PLM and its PTC Integrity solution.

PTC PLM implemented PTC Integrity as a single, end-to-end development platform, linking requirements, risks, mitigations, source code, tests, and quality records and enabling automated “one‑click” regulatory reports. The change enabled full traceability and RPN tracking, shortened iterative development cycles to about six months, allowed DHF generation without extra staff, sped audit responses, reduced costs through reuse of assets, and supported the first XR-1 implant built from start to finish with PTC Integrity.

CVRx