Recent Projects

Between the years 2019 and 2023 I provided clients with support in the following areas;

• 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
• Gap analysis and preassessment audits against requirements of ISO 17025, ISO 9001 & ISO 13485 & IEC 62304
• QMS and medical device Design History File auditing support to start up companies (SiMD & SaMD) prior to and during
• their ISO 13485 stage 1 and stage 2 certification audits.
• 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.
• 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;
• 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.