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ISO 13485 Compliance

ISO 13485: 2003 is an international standard, published in 2003, that outlines the requirements for a comprehensive management system for the design and manufacture of medical devices.

ISO 13485:2003 is recognized by the European Union, Japan, Australia and many other countries. Compliance with the standard is required by Canadian Medical Device Regulation. ISO 13485 is modeled on ISO 9000:2000 with the additional of requirements for documentation and provisions specific to medical devices. The standard is compatible with the requirements of the FDA QSR.

ISO 13485 also specifically requires risk management throughout the product life cycle. This is usually accomplished through implementation of ISO 14971:2007.

ISO 13485 also includes specific requirements for:

• The inspection and traceability for implantable devices
• Requirements for sterile medical devices
• Product cleanliness and contamination control

Certification to ISO13485 is the part of the most common route to an EC Declaration of Conformity with European Directives for Medical Devices, 93/42/EEC, Active Implantable Devices 90/385/EEC and In Vitro Diagnostic Devices 98/79/EEC.

MDCI will help you to design a single system that meets both ISO 13485 and FDA QSR requirements. We will prepare you for a third-party registrar (notified body) audit, to certify that your organization has met the ISO 13485 standard. We will also train your key staff to ensure a smooth and complete implementation.

Contact us today to learn how we can help you meet your ISO 13485 requirements.