Services

  • Quality System Auditing

    Quality Systems Auditor for Medical Device and Laboratory sectors

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  • Validation sterile barrier systems ISO 11607-1 and ISO 11607-2

    Validation Sterile barrier systems ISO 11607

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  • Training on ISO 13485, ISO 17025, Internal Quality Auditing & Estimation of Measurement Uncertainty

    Training

    ISO 13485, ISO 17025, Internal Quality Auditing & Estimation of measurement Uncertainty.

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  • Estimation of Measurement Uncertainty

    Support for ISO 17025 accredited laboratories

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  • Audit support for start up companies

    Medical Device Startups

    Gap analysis, pre certification audits prior to stage 1 and stage 2 audits against requirements of standards and regulations including ISO 13485, ISO 14971, IEC 62304, MDR & FDA CFR.

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  • Statistical Analysis

    Support with understanding standard deviation, control charts, proficiency scores and estimation of measurement uncertainty.

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  • Quality System Contractor

    Providing part time customised support with all aspects of your quality and regulatory requirements

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  • Quality Standards & Regulations

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Testimonials

The Uncertainty of Measurement training course went across very well. All concerned felt that it was set at just the right level for them as beginners approaching the subject for the first time. The worked examples were of great assistance in explaining the calculations involved...

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