Synopsis
The Biomedical Standards Industry Series consists of a series of in-depth briefing sessions/workshops for biomedical-related companies that are interested and ready for standards implementation. These workshops will cover new and existing standards.
Industry experts will share how they have leveraged on standards to address some of their challenges and opportunities in the field of med-tech devices manufacturing and distribution. Participants will also obtain insight on how standards can help their organisations gain market access, improve the quality of products, services and raise in-house productivity.
ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.
Objective
Singapore has adopted the ISO 14971:2007 as a Singapore Standard (SS).
The content of the SS ISO 14971:2017 is identical ISO 149871:2007.
Administrative Details
Programme is tentative and is subject to change at the sole discretion of Singapore Manufacturing Federation.
Should you require further information or assistance, kindly contact
Ms Cherie Ong at 6826 3039 / Mr She Long Huai at 6826 3102.
