Medical Devices Management Systems
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide Medical Devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Organizations involved in medical device industry see ISO 13485 as the de facto standard towards regulatory compliance.
Benefits of implementing ISO 13485 Management System
•Improved legal and regulatory or contractual requirements compliance
•Assistance in monitoring supply chain effectiveness
•Increased profit margins
•Improved product safety
•Proactive error detection and prevention
•More Effective Risk Management
•Increased likelihood of meeting Customer Requirements
Benefits of ISO 13485 Certification to the clients:
•Quality ensured medical devices
•Safe and effective medical devices
•Lower skepticism and increased confidence for end-customer
ISO 13485:2016 certification is a third-party audit performed by PQS, upon verification that an organization is in compliance with the requirements of standard, will issue compliance certificate. Certification is then maintained through regularly scheduled annual surveillance audits, with re-certification performed on a triennial basis.