ISO 13485:2016 The most recognized international standard specifically developed for the manufacture of medical devices. It applies to manufacturers and organizations that support them.
The standard aims to ensure devices consistently meet customer and applicable regulatory requirements.
ISO 13485 includes the need for a risk-based approach to the quality system, enhanced focus on regulatory requirements, the responsibilities of top management, increased controls over suppliers and outsourced activities, and emphasis on risk management throughout the product lifecycle.
Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry
The FDA’s Adoption of ISO 13485: What Medical Device Manufacturers Should Know – click FDA and let HSMS assist you further for an approval