Selection of Previous Projects


  • Internal audits over a 2 year period for a class III device manufacturer, auditing against requirements of ISO 13485, EU MDD, EU MDR, MDSAP & FDA (CFR Part 11, Part 820, Part 803, Part 806 & rolling 6-monthly audits on FDA CFR Part 821 Medical Device Tracking.
  • Hosting external audit by Notified Bodies and inspections by Competent Authority against requirements of EU MDR, ISO 13485, ISO 9001 & ISO 14001.
  • Gap analysis and preassessment audits against requirements of ISO 17025, ISO 9001 & ISO 13485 & IEC 62304
  • QMS and Medical Device Design History File auditing for start up companies (SiMD & SaMD) prior to and during their ISO 13485 stage 1 and stage 2 certification audits.  Audit included requirements of IEC 62304.
  • Unannounced audits & supplier audits across Europe and the US for a multinational medical device manufacturer
  • Performed full set of internal audits against requirements of ISO 9001 for a laundry service provider.
  • Audits of QMS for medical device contract manufacturer against requirements of ISO 13485 & ISO 9001.
  • QMS audit readiness audits for a medical device start-up company.  Stage I and Stage II certification audits by Notified Body passed with no findings.
  • Estimation of measurement uncertainty in physical, chemical, and microbiological testing laboratories.
  • Quality contractor providing support with sterile packaging validation as part of EU MDR remediation project against requirements of ISO 11607-1 & ISO 11607-2.
  • Statistical support with understanding calculations behind control charts, regression analysis and correlations.
  • Quality contractor providing support with complaints management and CAPA.
  • Statistical support for laboratory staff with proficiency test results and calculations.
  • Delivery of training courses on;
    • EU MDR for Importers and Distributors of Medical Devices
    • ISO 17025:2017
    • ISO 13485:2016
    • Internal Quality Auditing
    • Estimation of Measurement Uncertainty for testing laboratories in the Food Sector
    • Estimation of Measurement Uncertainty for testing laboratories in the Life Science Sector
    • Understanding reports from testing laboratories - for clients of test labs.
    • Understanding and Interpretation of Calibration Certificates.
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