This 2 day special ISO 14971:2007 Risk Management training program is intended as an introductory course to enable participants to have a basic understanding of Risk Management for Medical Devices.
Participants of this program will be provided with a basic understanding on the requirements of ISO 14971:2007, the ISO standard which specifically addresses the concerns of Risk Management for medical devices.
Objectives of this training
· To enable participants to understand the systematic approach towards measuring risks to produce safe and effective medical devices.
· To understand and effectively develop and implement systematic application of management policies, procedure and practices to identifying, controlling, and monitoring risks to conform to the requirements of ISO 14971:2007 and meet the ISO 13485:2003 Clause 7.1 Planning of Product realization.
· How to minimize / reduce errors or deficiencies that was designed into particular devices that may have been prevented by adequate design and development control.
· Enable participants to differentiate between Risk Analysis and Risk Management.
Jane Lim, Manager, Public Relations
T +65 6885 1527 F +65 6776 8670