Learn in this Q&A what the similarities and differences are in ISO 13485 and 21 CFR 820. Also learn what MasterControl’s connection is to these 2 regulations and how we can help you in compliance.
ISO 13485 compliance helps ensure that companies will meet the FDA's requirements for 21 CFR Part 820 for quality system regulations.
Compliance with ISO 13485 is often seen as the first step in complying with European regulatory standards.
ISO 13485 helps companies maintain efficient and holistic quality management processes and reflects a strong commitment to continuous improvement.
ISO 13485:2016 has quickly become the global standard for medical device quality requirements. A comprehensive ISO 13485 overview will help your company meet the standard faster and more cost effectively.Get Your Free White Paper