Management System in production and handling of medical devices (MSDS)

ISO 13485 outlines the requirements for a quality management system (QMS) related to medical devices. It focuses on ensuring that organizations consistently provide medical devices and related services that meet customer expectations and comply with strict regulatory requirements. Improved safety practices lead to better product quality and patient safety.

ISO 13485 is upgraded ISO 9001, places greater emphasis on risk management associated with medical devices. It covers various stages, including design, development, production, storage, distribution, installation, and servicing of medical devices, also addressing associated activities like technical support.

Compliance with this standard enhances marketability and facilitates global recognition. ISO 13485 aligns with the FDA’s Quality System Regulation (21 CFR Part 820). It provides guidance for EU medical device manufacturers and supports regulatory compliance.

Benefits include:

• Enhanced product quality.
• Regulatory compliance.
• Improved customer confidence and trust.
• Improved risk management.
• Access to global market.
• Better supplier relationship manager.

ISO 13485 plays a crucial role in ensuring the safety, quality, and reliability of medical devices.