Case Study: Puzzle Medical Devices achieves accelerated go-to-market and streamlined quality management with Greenlight Guru

Putting Together the Pieces for Success With Greenlight Guru

Puzzle Medical Devices, developer of the ModulHeart Class III device, faced strict regulatory and manufacturing challenges—needing exact, repeatable prototypes, new test methods, clear regulatory and development documentation, supplier criteria, and tighter quality control across their supply chain. To address these requirements they partnered with Greenlight Guru and adopted Greenlight Guru’s eQMS to organize design controls, testing, and supplier information centrally.

Using Greenlight Guru, Puzzle Medical Devices implemented a fully traceable Design Control Matrix linked to risk management, conducted design reviews and automatically generated DHF content, began compiling DMR documentation, and streamlined CAPA, nonconformance, and audit workflows. The vendor’s solution helped Puzzle accelerate time to market by 5 months, save an estimated 360 hours per employee annually, achieve 100% training compliance, and positioned the company to move into human clinical trials and pursue ISO 13485 certification.

Puzzle Medical Devices

Jade Doucet-Martineau

Co-founder & Chief Executive Officer