ISO 13485:2016

Quality Management System for medical device industry

ISO 13485:2016 is an international standard which specifies the necessity for a Quality Management System for the Medical Device industry. The objective of this standard is to provide a framework for companies to meet their customer and regulatory requirements in the medical industry. ISO 13485 is a widely accepted global standard to address the medical device industry around the globe. This standard is for the organizations which are involved in the design, development, production, storage, distribution, installation, servicing or technical support of a medical device.

The main goal is to provide a harmonized model for QMS requirements in the international market since different countries might have different standards. While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. It includes some particular requirements for medical devices with emphasis on :

• The promotion and awareness of regulatory requirements as a management responsibility.
• Controls in the work environment to ensure product safety.
• Focus on risk management activities and design transfer activities during product development.
• Inspection and traceability for implantable devices.
• Documentation and validation of processes for sterile medical devices.
• Verification of the effectiveness of corrective and preventive actions.

Compliance with ISO 13485

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European Union regulatory requirements. With European Compliance Assessment (ECA), we have no preconceived ideas on how you should apply quality management to your business. It is your company, and you know the best way to apply the requirements of the appropriate standard. Our role is to assess whether your management system does in fact comply with the relevant standard regardless of how you have done it!

We at ECAS Certifications provide various ISO certifications and ISO 13485 for Medical Device Industry as well.

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