Greenlight Guru recently announced the introduction of its Grow software product to assist medical device companies with quality management after product launch.
The Indianapolis-based company’s first product, Go, focused on helping medtech companies utilize design control, risk management and document management software to bring FDA and ISO-compliant medical devices to market in less time.
Many medical device companies, though, are placing themselves at risk of Corrective and Preventive Actions (CAPA) with FDA after product launch because they still use paper-based systems to connect the disparate processes, sources, people and data within a quality system, according to Greenlight Guru.
“After experiencing this pain firsthand working in product development and management for medical device companies, I knew there needed to be an easier way to help companies not only get to market faster but improve their post-market quality processes beyond just compliance,” Jon Speer, founder and VP of QA/RA at Greenlight Guru, said in a news release.
“Grow has additional workflows for CAPA and other post-market needs that will help these companies who are flying blind without visibility into their quality system and are subject to unnecessary risk,” Speer said.
Grow features include:
- CAPA management;
- Customer feedback management;
- Nonconformance management;
- Audit management;
- Change management;
- Training management.
“Companies can now use quality as an accelerator, confidently connecting all the pieces of their quality system to get the visibility they’ve been missing, leading to higher quality devices, better business and ultimately, better lives,” said David DeRam, co-founder and CEO at Greenlight Guru.