ISO 13485 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM

Standard Introduction

ISO 13485 is a medical device quality management system requirement for regulatory purposes, and it is also a quality management system standard widely adopted by the medical device industry.

This standard is added risk management (ISO 14971 Risk management), quality management system software confirmation, product cleaning, installation, special services, special process confirmation, sterilization process confirmation, Software life cycle management, implantable medical material-Special provisions for the medical device industry such as post-market supervision and notification. After years of promotion and development, ISO 13485 has become a quality management system standard recognized by global medical device regulatory agencies and is applicable to the entire medical device industry supply chain.

Certificate Verification Benefit

• Improve company image and product value

• Strengthen the ability and opportunity to enter the international medical industry supply chain to suit the industry

• Break through the barriers of international trade and expand the global medical equipment market

• Reduce the risk after the product put into market

Applicable industry

Medical Device Manufacturers, Innovative Research and Development Companies, Final-End Product Manufacturers, Key Component Suppliers, Special Process providers, Sterilization Service Providers, After-Sales Service Providers, Warehousing and Logistics Service Providers, Distributors/Sellers

Training Course

• ISO 13485 Medical Device Management System Internal Auditor Training Course

• ISO 14971 Medical Device Risk Management Requirements

• IEC 62304 Medical Device Software Life Cycle Management

• IEC 62366-1 Medical Device Usability Engineering