The United States FDA requires medical device companies that market products in the U.S. to maintain a quality system subject to audit by FDA inspectors. Without a quality management system in place to manage your quality system—and verify and validate its effectiveness—you run the risk of non-compliance, costly redesigns, and delayed time-to-market.
You’re not in it alone! We partner with Greenlight Guru to help our customers navigate these hurdles. Greenlight Guru helps MedTech companies manage their quality, regulatory, clinical, and product development activities across the entire device lifecycle in a single, purpose-built platform.
Quality touches every aspect of your business all the way to the health of patients. By working with Greenlight Guru, you will be poised to deliver innovations to market, streamline compliance, and focus on quality—and, ultimately, improve the quality of lives.
To learn more about Greenlight Guru Quality Management Software, contact us here.
March 29, 2021
February 27, 2023