ISO 13485 Medical Devices FAQ

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1. What is ISO 13485?
ISO 13485 is the globally recognised management systems standard for the design, manufacture, installation and servicing of medical devices.  It is a framework to facilitate compliance with the differing regulatory requirements of different marketplaces around the world.
2. What are the key requirements of ISO 13485?
While encompassing the core elements of the ISO 9001 Quality Management System, ISO 13485 differs in a number of respects.  The primary difference is its focus on regulatory compliance rather than customer satisfaction or continuous improvement as found in ISO 9001.  Other key elements include:
  • A strong focus on risk management in the design and development process
  • Product traceability and recall
  • Process validation
3. What are the benefits of ISO 13485 compliance?
The primary benefit for most organisations operating at any tier of the medical device supply chain is the enhanced ability to win business in this sector – particularly when non ISO13485 cetificated organisations may be excluded from the procurement process.  However there are other benefits including:
  • Improved standing in the marketplace
  • Higher levels of customer satisfaction
  • Improved efficiency from improved working practice
  • Improved management of risk
4. How can HPA help?
Through every stage of the process, Hatton Parkinson Associates can help your business to prepare for third party assessment for the ISO 13485 standard. We partner with you at every step to make sure the whole compliance experience is as simple and cost effective as it can be.
5. What does this cost?
The straightforward answer is that ISO 13485 certification does not cost that much compared to the benefits of becoming registered. Government grants of up to half the fees may be available.  Our own in-house payment plan options can also help to spread the cost.