GrassrootsDX offers a DIY QMS Regulatory Kit with a quality management system template built around ISO 13485:2016 and FDA requirements under 21 CFR Part 820. Digital health startups, medical device manufacturers, and IVD teams can use the customizable SOPs, forms, and quality manual to set up or remediate their quality system. The kit also includes SOAR training and a live Q&A session with a quality and regulatory expert. Contact GrassrootsDX to learn more about the DIY QMS Regulatory Kit and how it can help you build a structured quality system.