Day Rate: 425
Type of service :
  • Design/Create/Install new system
  • Maintain existing system
  • Internal Audits
  • Consultancy (general improvements, strategic approaches, enhancements)
ISO Standard :
  • ISO 9001 Quality
  • ISO 13485 Medical Devices
  • ISO 15189 Medical Laboratory

Recently worked with a Medical Device client for Class I (M) and IIb in Devon, transferring ISO certification; aligning QMS including CAPA and Change Control. Conducted MDSAP Gap Analysis and Client has now achieved MDSAP Certification. Now working on MDR Gap Analysis, remediation of CAPAs, setting up a CRB and planning internal audit course specific to the client. Conducted Post Market Surveillance, reviewing FMEA.

Other work was with a National Training Organisation to update and deliver amongst others, the following:

  • Introduction to ISO 13485:2016
  • ISO 13485:2016 Internal Auditor (2 days)
  • Risk Management and FMEA for Medical Devices (2 days)
  • ISO 14971 Risk Management
  • BS EN 62366 Application of Usability Engineering
  • ISO 15189 Medical Laboratories Requirement for Quality and Competence
  • Quality System Regulations (FDA)