CONSULTANT Mick P

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)