Limehill Quality Solutions Ltd

I partner with Life Science companies from start ups to SMEs to large multinationals offering portfolio of professional consulting services that can be customised to suit your needs.  My background in quality management & statistical techniques enables me to support clients with regulatory requirements, quality control, proficiency testing, validation, and estimation of measurement uncertainty.

 

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 ISO9001 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.

• 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

  • ISO17025:2017

  • 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.

​

I put great value in the quote from the visionary and master of continual improvement of quality, Dr. W. Edwards Deming. “There is no substitute for knowledge”

​

​