Product validation services, medical device validation

By: Trend Technologies  05/12/2011
Keywords: medical devices, Product Introduction, Product Validation

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Trend Technologies provides exceptional engineering support and manufacturing excellence for the automotive and medical devices markets. We have a deep understanding of these sectors, and the need to meet exacting product requirements and comply with international standards and regulatory guidelines.

Our experience with plastic component approvals means that our Quality Department can manage all aspects of programme validation as part of new product introduction (NPI)

We apply best practice principles to the approval stages of all  programmes as well as ongoing production requirements.

Protocols and test reports

If you are introducing a new product, our team will liaise with you to develop and agree validation protocols to cover all aspects of the qualification process, including moulds, machines, materials, processes and equipment.

We prepare a documented validation protocol at the outset of the programme, which will include:

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)

We then prepare separate test reports for each stage of the qualification and these are signed off by the Quality, Engineering and Technical team.

Windows studies are used to challenge the process capability and dimensional stability of components. We undertake and manage all measurement activity for the qualification as required, and our final test report will incorporate a summary of the test findings and observations.

A final test is issued at the conclusion of the validation and is signed off by our Quality Department. All documentation relating to the approval is centrally filed and available for review by customers or regulatory authorities.

Keywords: medical devices, Product Introduction, Product Validation

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