ISO 13485Medical Devices

It goes without saying that safety and quality are essential at every point of the life cycle of medical devices, all the way from design through to operation and disposal. Obtaining ISO 13485 accreditation will help your business meet the stringent standards and many regulatory requirements in this field by adopting clear quality management processes and best practices.

Key Benefits

of ISO 13485

  • Internationally recognised, this is the most accepted global standard of its kind for medical devices.
  • Encourages efficiencies and quicker cycle times that lead to process improvements and cost savings.
  • Helps your business to reduce waste across all parts of the production process.
  • Improves reliability leading to an increase in customer satisfaction and potential for repeat sales.
  • Provides a competitive edge and marketing advantage based on quality assurance in a crowded marketplace.

How we work with you:

All ISO accreditations follow the same process:

Step 1:Gap Review

An ISO QA Consultant will visit your business to review and document your current processes and procedures, highlighting any areas that do not meet the requirements of the Standard.

Step 2:Implementation

Now it’s time to make sure any required process or procedural changes are made, as highlighted in the Gap Review. ISO QA will work with you every step of the way to make these changes.

Step 3:Certification

An Auditor visits your business to check that the documented processes are being followed and that the necessary changes have been made. Once they are satisfied, you will be awarded your certification.


Call 0330 043 5101

Head office
ISO QA Isle of Man Limited
Design House (18B)
Carrs Lane
Isle of Man

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