Medical Devices Quality Management System – ISO 13485
What is ISO 13485?
Strengthen quality. Support patient safety. Build confidence.
What is it?
ISO 13485:2016 is the international standard for Quality Management Systems in the medical device industry. It helps organizations consistently provide medical devices and related services that meet customer and applicable regulatory requirements.
The standard applies to organizations involved in the design, development, production, storage, distribution, installation, and servicing of medical devices, as well as relevant suppliers and service providers.
Key areas include risk management, documentation, supplier controls, process validation, traceability, complaint handling, and corrective and preventive actions.
Why get certified?
ISO 13485 certification demonstrates your commitment to effective quality management in a sector where safety and reliability are essential. It helps your organization:
Build customer confidence among healthcare providers, distributors, and business partners.
Support regulatory compliance through structured processes and documented controls.
Manage quality risks throughout product realization.
Strengthen operational control through supplier evaluation, process validation, and traceability.
Support business opportunities in tenders and medical device supply chains.
Maintain system effectiveness through audits, performance monitoring, and corrective actions.
QME provides EGAC-accredited ISO 13485 certification, helping organizations demonstrate their commitment to effective medical device quality management.
Certification covers your quality management system and does not replace medical device approval or registration.
Contact QME to discuss your certification needs and request a quotation.
Email: qme@qme-eg.com