Independent reviewer
Encyclopedia
The US Food and Drug Administration
requires that developers of medical device
follow a system of design controls
. A key part of this system is design review, defined in 21CFR820.3 section (h) as "a documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems."
In 21CFR820.30 section (e), it is stated that an independent reviewer is required for any design review. An independent reviewer is an individual who does not have direct professional responsibility
for the design stage under review
, assuring an independent and objective review. Within the context of formal design reviews, the practical solution is simply to ensure a fresh perspective, based on the principle that those who are too close to the design
may overlook
design errors. Thus, reviewers should not have been significantly involved in the activities under review
.
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
requires that developers of medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
follow a system of design controls
Design controls
Design Controls designates the application of a formal methodology to the conduct of product activities.It is often mandatory to implement such practice when designing and developing products within regulated industries Design Controls designates the application of a formal methodology to the...
. A key part of this system is design review, defined in 21CFR820.3 section (h) as "a documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems."
In 21CFR820.30 section (e), it is stated that an independent reviewer is required for any design review. An independent reviewer is an individual who does not have direct professional responsibility
Professional responsibility
Professional responsibility is the area of legal practice that encompasses the duties of attorneys to act in a professional manner, obey the law, avoid conflicts of interest, and put the interests of clients ahead of their own interests....
for the design stage under review
Review
A review is an evaluation of a publication, a product or a service, such as a movie , video game, musical composition , book ; a piece of hardware like a car, home appliance, or computer; or an event or performance, such as a live music concert, a play, musical theater show or dance show...
, assuring an independent and objective review. Within the context of formal design reviews, the practical solution is simply to ensure a fresh perspective, based on the principle that those who are too close to the design
Design
Design as a noun informally refers to a plan or convention for the construction of an object or a system while “to design” refers to making this plan...
may overlook
Overlook
A scenic overlook, or just an overlook, observation point, lookout or viewing point, is a high place where people can gather to view scenery , and to photograph it. Scenic overlooks are typically created alongside mountain roads, often as a simple turnouts where motorists can pull over onto...
design errors. Thus, reviewers should not have been significantly involved in the activities under review
Review
A review is an evaluation of a publication, a product or a service, such as a movie , video game, musical composition , book ; a piece of hardware like a car, home appliance, or computer; or an event or performance, such as a live music concert, a play, musical theater show or dance show...
.