ISO 13485 MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM

ISO 13485:2016, the most updated international standard of medical device quality management system. This standard had been recognized by global regulatory authorities of medical devices including USFDA and EU, and/or harmonized within specific regulatory requirements of medical devices. Its requirements are fundamental basis for county based GMP, MDSAP, EU MDR, on quality management system requirements. Key activities including management review and internal audit to ensure manufacturers’ quality management system meeting ISO 13485 requirements, are crucial to enhance regulatory compliance of the quality management system.

Introduction

ISO 13485 are applicable to QMS of medical devices for regulatory purposes. Its requirements are adopted by international regulatory authorities, as well as industries of medical devices, into standardized basis. ISO 13485:2016 as the most updated revision, integrated requirements and suggestions of ISO 14971 at risk management, QMS software validation, product cleanliness, installation, service regarding medical devices, process validation, sterilization validation, medical device software life cycle management, traceability of implantable medical devices, PMS and reporting. ISO 13485 certification through long-run development and implementation, had been recognized by global medical device regulatory authorities at verification of QMS of medical devices, and applicable for supply chain management of medical device industries.

Benefits

Enhancement of industry image and product value-added
Strengthen the capability and oppoturnity of penetration to international supply chain of medical devices
Breaking the ground of international trade barriers, expanding global markets of medical devices
Establishment of risk management appropriately to reduce risks of medical devices at pre-market and post-market stages

Applicable To

Medical device manufacturers, innovational companies, final product manufacturers, critical component providers, special process providers, contracted sterilizers, post-market service providers, warehouse/transportation providers, distributors, retailers

Training Courses
ISO 13485 Medical Device QMS Introduction