What is ISO 13485?
internationally recognized standard for Quality Management Systems (QMS) specific to the medical device industry. It outlines requirements for the design, production, installation, and servicing of medical devices to ensure safety, efficacy, and regulatory compliance. It is a voluntary standard aimed at manufacturers and suppliers, focusing on risk management and consistent quality.
What are the benefits of ISO 13485certification?
- Market Access: Helps meet regulatory requirements in major international markets.
- Safety: Ensures consistent, safe, and high-quality medical devices.
- Efficiency: Improves operational efficiency and traceability.