ISO 14971:2007 – Application of Risk Management to Medical Devices

ISO 14971:2007 – Application of Risk Management to Medical Devices

Risk management is one of the complimentary requirements in ISO13485 Medical Devices Management System. There are many tools available nowadays in assisting companies to implement the risk management, and ISO 14971 is an international standard that is quickly being recognized as one of the best processes to ensure that all aspects of risk management are considered throughout the product lifecycle for medical devices. This international standard is recognized by the US Food and Drug Administration (FDA), Canada (CMDCAS), Australia (TGA), Japan (PAL) and Malaysia (Medical Devices Bureau, MDB) as the “de facto” standard for risk management, and it’s harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC.

In year 2007, the ISO 14971:2007 is published to supersede earlier ISO 14971:2000, which expired on 30th of March 2010. There are changes in this new version of ISO 14971 in terms of terminology, definitions, as well as requirements. As certification partner, DQS Malaysia think there is a need for us to educate our clients on the changes.

On 11th of June 2010, a seminar has been conducted by Mr. Danny Ng, Lead Tutor on medical devices standards and regulatory requirements, on ISO 14971:2007 Risk Management for Medical Devices. This seminar not only highlighted those changes in ISO14971:2007 compared to the 2000 version, it also aimed to educate participants on how this harmonized standard can be implemented to meet the essential requirements of the medical devices directives and regulatory requirements. A practical understanding was emphasized so that it’s applicable in day to day business and not just about compliance to the standard.

We were glad received proactive response from our clients in making this seminar a success. We hope the seminar added value to all the participants, as we always emphasize, this is what a certification partner should do.


Mr. Danny Ng (center), Tutor of the seminar, is giving explanation during the seminar