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:
Consultant : CONSULTANT Mick P
1) ISO 9001 Quality
2) ISO 13485 Medical Devices
3) ISO 15189 Medical Laboratory
1) Design/Create/Install new system
2) Maintain existing system
3) Internal Audits
4) Consultancy (general improvements, strategic approaches, enhancements)
Enquiry ID : V-ENQ-70314
Date Stamp : October 8, 2024