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ISO 13485 / Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

What is ISO 13485?

ISO 13485 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for:

1) Implementation of a Quality Management System with several enhancements
2) Risk Management approach to product development and product realisation
3) Validation of processes
4) Compliance with statutory and regulatory requirements
5) Effective product traceability and recall systems

Is ISO 13485 right for me?

ISO 13485 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. Annex B of the ISO 13485 standard includes a comparison with ISO 9001 for reference. Importantly, neither can be used to make a QMS that is automatically compliant to the other and both need auditing.

Further, there are many terms in ISO 13485 unique to medical devices. ISO 13485 also retained the role of a quality representative to top management where ISO 9001 removed this in many aspects. Interestingly ISO 9001 has a lot more requirement for monitoring external providers for performance than the old version and this is something always required by ISO 13485.

Who is it applicable to?

ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.

What are the benefits of ISO 13485 / Medical Devices?

1) Increase access to more markets worldwide with ISO 13485 certification
2) Outline how to review and improve processes across your organisation
3) Increase efficiency, reduce costs and monitor supply chain performance
4) Demonstrate that you produce safer and more effective medical devices
5) Meet regulatory requirements and customer expectations

How PSV can support your medical device business?

We understand the specific challenges medical device manufacturers face and the importance of bringing innovative yet safe products to global markets. Ensuring the predictability and transparency of regulatory product clearance is key to maintaining a competitive edge.

Our commitment to excellence

Manufacturers tell us they need to work with a highly competent, customer focused Notified Body that understands the specifics of their environment and the importance of complete confidentiality around patent pending new technology. Our services are designed to align with the steps individual clients need to take to understand what is best practice, how to achieve it and ensure that it remains an ongoing habit. We provide rigorous quality management reviews and product certifications for medical device manufacturers around the world, and we can do it for you too.

“Necessary certification, trade in your target markets, assurance you need anywhere in the world”