Design controls
Encyclopedia
Design Controls designates the application of a formal methodology
to the conduct of product
activities.
It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. Medical devices).
(FDA) requires that medical device
manufacturers who want to market certain types of medical device in the USA follows the Design Control requirements formulated in 1996, Design Controls (21 CFR 820.30).
The Medical devices directive
similarly lists several requirements regarding the design of a medical device.
ISO 13485
contains section 7.3 Design and Development which specify what procedures have to be put in place by manufacturers.
The objective of Design Controls, in this context, is to guarantee manufacturers follow a methodologically-sound process to develop a medical device, which in turns ensures, or at least improves the probability, that the device will reach an acceptable level of efficacy
and safety.
Design management
Design Management is a business discipline that uses project management, design, strategy, and supply chain techniques to control a creative process, support a culture of creativity, and build a structure and organisation for design...
to the conduct of product
New product development
In business and engineering, new product development is the term used to describe the complete process of bringing a new product to market. A product is a set of benefits offered for exchange and can be tangible or intangible...
activities.
It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. Medical devices).
Medical devices
The Food and Drug AdministrationFood 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...
(FDA) requires that 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,...
manufacturers who want to market certain types of medical device in the USA follows the Design Control requirements formulated in 1996, Design Controls (21 CFR 820.30).
The Medical devices directive
Medical Devices Directive
The Medical Device Directive is intended to harmonise the laws relating to medical devices within the European Union...
similarly lists several requirements regarding the design of a medical device.
ISO 13485
ISO 13485
ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices...
contains section 7.3 Design and Development which specify what procedures have to be put in place by manufacturers.
The objective of Design Controls, in this context, is to guarantee manufacturers follow a methodologically-sound process to develop a medical device, which in turns ensures, or at least improves the probability, that the device will reach an acceptable level of efficacy
Efficacy
Efficacy is the capacity to produce an effect. It has different specific meanings in different fields. In medicine, it is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances.- Healthcare :...
and safety.