Auditing & Surveillance
The Compliance Department of the IMB carries out audits of medical device manufacturers on a regular basis. The type of audits that are conducted are as follows:
Proactive post-market surveillance audits
'For cause' post-market surveillance audits
Custom-made medical device audits
Other audits pertaining to the register of medical devices
For more details on the type of audits please see;
IMB Guide for Medical Device Manufacturers on Auditing by the Irish Medicines Board to the Medical Device Regulations; and also
IMB Guide for custom-made Medical Device Manufacturer on Compliance with European Communities (Medical Devices) Regulations, 1994.
The aim of these audits is to ensure that the medical device manufacturer is complying with the 'Essential Requirements' and schedules of the Medical Device Directives and related Statutory Instruments.
Another key area in which the audit team is involved in is the surveillance of the medical device market to identify issues and trends in order to highlight priority areas for the medical devices market.
If you wish to obtain further information on auditing activities please contact a member of the audit team at firstname.lastname@example.org