ISO 13485:2011

EMS

Protecting the integrity of the medical device industry!!

ISO 13485 is an international standard that specifies requirements for regulatory purposes for medical device manufacturers. It provides a framework for companies to meet their customer and regulatory requirements. It is becoming widely accepted as the international standard to address medical device requirements around the world. The main goal is to provide a harmonized model for quality management system 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.
• Specific requirements for inspection and traceability for implantable devices.
• Specific requirements for documentation and validation of processes for sterile medical devices.
• Specific requirements for verification of the effectiveness of corrective and preventive actions.

 

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European Union regulatory requirements. With Euro Conformity 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!