Why Cloud QMS Better Supports Regulatory Compliance
- Magazine Article
- TBMG-34806
Sector:
Language:
- English
Topic:
Companies regulated by the U.S. Food and Drug administration (FDA) need to establish current good manufacturing practices (CGMPs) as part of Title 21 CFR part 820 requirements. This includes creation of quality systems to ensure development of safe and effective devices. More specifically, medical device manufacturers must establish methods and procedures to design, produce, and deliver devices that meet the quality system standard.1