Quality Consultant, Auditor and Trainer with over 25 years of experience with Quality Systems, ISO Standards and Regulations across Europe and the US. We work with Medical Device Start-ups, Established Medical Device Manufacturers, ISO 17025 Testing Laboratories, Calibration Laboratories, Life Science SMEs, & Regulatory Affairs Teams
Services
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Training for Medical Device Sector
Learn MoreEU MDR for Importers & Distributors, ISO 13485, ISO 17025, Interpreting Test and Calibration Certificates & Internal Quality Audits.
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Training for Laboratory Sector
Learn MoreEstimation of Measurement Uncertainty, Understanding & Interpreting Test Certificates and Calibration Certificates, ISO 17025 and Internal Quality Auditing
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Validation Sterile barrier systems ISO 11607
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Medical Device Startups
Learn MoreGap 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
Learn MoreSupport with understanding standard deviation, control charts, proficiency scores and estimation of measurement uncertainty.
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Quality System Contractor
Learn MoreProviding part time customised support with all aspects of your quality and regulatory requirements
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Contact Us
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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...