Quality/Regulatory

Attention to details!

  • Regulatory filing strategies created for EU and FDA submissions for low, medium and high risk IVDs for EU and US based SMEs
  • UK based site regulatory manager for a global multinational company undergoing reorganisation and restructuring. Contract lasted 9 months for 20 hours a week.
  • Review of technical files to provide an external opinion prior to self-certification of the CE Mark for UK based SME.
  • ISO13485 compliant quality systems initiated and implemented for UK and Asian based SMEs .
  • Internal audits conducted for UK and Asian based SMEs
  • Set up and Managed QA system for small Asian company with successful ISO13485/9001 audits
  • Supplier audits for UK-based supplier for a US headquartered global multinational life sciences company.
  • Provide training on the IVDD, US FDA registration, ISO 13485 and risk management.