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Risk management is a process
for identifying, evaluating and mitigating risk. For medical devices, this refers
to product safety and includes risks associated with harm to people and damage
to property or the environment. Risk management has become an integral part of
medical device design and development, production processes and evaluation of
field experience. Risk management is applicable to all types of medical devices
and evidence of its application is required by most regulatory bodies.
The management of risk for
medical devices is described a product safety standard by the International
Organization for Standardization (ISO) in ISO
14971:2019, Medical devices—
Application of risk management to medical devices.. Accordingly, this course
examines this standard using specific examples. Topics addressed include
management responsibilities, risk analysis and evaluation, risk controls and
lifecycle risk management.
This course is not intended
for implementing Enterprise Risk Management. Rather, this course is oriented to
product safety risk management, which is a separate process. It is important to
remember throughout the course that the focus is on product safety for people
(not just the patient), property and the environment.
The European version of the
risk management standard was updated in 2009 and again in 2012 to refer to the Medical Devices Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) revision in 2007, as well as the In Vitro Medical Device Directive (IVDD). The requirements of EN 14971:2012 are identical to ISO
14971:2007. The only difference is in the Informative Annexes ZA, ZB, and ZC,
which refer to the new MDD and AIMDD as well as the IVDD. When referring to ISO 14971:2007,throughout this course, it
is understood that this includes the EN version of the standard as revised in
The European Medical Device
Regulations (MDR, 2017/765) and European In Vitro Device Regulation (IVDR,
2017/766) will replace the Medical Device Directives and the Active Implantable
Medical Device Directives in May of 2021, as well as the In Vitro Device
Regulation which will replace the In Vitro Device Directives in May of 2022.
The most recently released version of ISO 14971, released in May 2019, reflects
the requirements of these regulations. It is important to note that while ISO
14971:2019 is considered to be the state-of-the-art, it is not yet harmonized
to either the MDD/AIMDD/IVDD or MDR/IVDR.
At A Glance
Upon completion of this course, participants should be able to: