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Design Controls
Design controls designates the application of a formal methodology to the conduct of product development 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 Since 1990, the Food and Drug Administration (FDA) has required that medical device manufacturers that want to market certain categories of medical devices in the USA follow Design Control requirements (21 CFR 820.30). At a high level, this regulation requires: * Design and development planning * Design input, including intended use and user needs (also known as customer attributes) * Design output, including evaluation of conformance to design input requirements through: ** Design verification confirming that the design output meets the design input requirements ("did we design the device right?") ** Design validation ensuring that the devices conform to defined user needs and intended uses ( ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Design Management
Design management is a field of inquiry 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 organization for design. The objective of design management is to develop and maintain an efficient business environment in which an organization can achieve its strategic and mission goals through design. Design management is a comprehensive activity at all levels of business (operational to strategic), from the discovery phase to the execution phase. "Simply put, design management is the business side of design. Design management encompasses the ongoing processes, business decisions, and strategies that enable innovation and create effectively-designed products, services, communications, environments, and brands that enhance our quality of life and provide organizational success." The discipline of design management overlaps with marketing management, operations management, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Design Transfer
A design is a plan or specification for the construction of an object or system or for the implementation of an activity or process or the result of that plan or specification in the form of a prototype, product, or process. The verb ''to design'' expresses the process of developing a design. In some cases, the direct construction of an object without an explicit prior plan (such as in craftwork, some engineering, coding, and graphic design) may also be considered to be a design activity. The design usually has to satisfy certain goals and constraints; may take into account aesthetic, functional, economic, or socio-political considerations; and is expected to interact with a certain environment. Typical examples of designs include architectural and engineering drawings, circuit diagrams, sewing patterns and less tangible artefacts such as business process models. Designing People who produce designs are called ''designers''. The term 'designer' generally refers to someone who wor ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Efficacy
Efficacy is the ability to perform a task to a satisfactory or expected degree. The word comes from the same roots as ''effectiveness'', and it has often been used synonymously, although in pharmacology a pragmatic clinical trial#Efficacy versus effectiveness, distinction is now often made between efficacy and effectiveness. The word ''efficacy'' is used in pharmacology and medicine to refer both to the maximum response achievable from a pharmaceutical drug in research settings, and to the capacity for sufficient therapeutic effect or beneficial change in clinical settings. Pharmacology In pharmacology, efficacy () is the maximum response achievable from an applied or dosed agent, for instance, a small molecule drug. Intrinsic activity is a relative term for a drug's efficacy relative to a drug with the highest observed efficacy. It is a purely descriptive term that has little or no mechanistic interpretation. In order for a drug to have an effect, it needs to bind to its t ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ISO 13485
ISO 13485 ''Medical devices -- Quality management systems -- Requirements for regulatory purposes'' is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). The current ISO 13485 edition was published on 1 March 2016. Background Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
EU Medical Device Regulation
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021. The regulation was published on 5 April 2017 and came into force on 25 May 2017. Originally approved medical devices will have a transition time of three years (until 26 May 2021) to meet new requirements. Changes Changes compared to the Medical Device Directive include changes in device classification and device scope, stricter oversight of manufacturers by Notified Bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC) and of the economic operator concept, the requirement of Unique Device Identification marking for devices, EUDAMED registration (see below), UDI requirements, and increased post-market surveillance activities. Scope and classification ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Devices Directive
The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certificat ... applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised direct ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Design History File
A design history file is a compilation of documentation that describes the design history of a finished medical device. The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient. Prior to this legislation, U.S. Food and Drug Administration (FDA) auditors were limited to examining the production and quality control records of the device. Requirements The regulation requires medical device manufacturers of Class II and Class III devices to implement design controls. These design controls consist of a development and control plan used to manage the development of a new product, and a design history file where these activities are documented. These controls are specifically intended to manage a medical device company's new product development activities. Research and developm ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Design Change
A design change is the modification conducted to the product. It can happen at any stage in the product development process. The design changes that happen early in the design process are less expensive when compared to those that take place after it is introduced into full-scale production. The cost of the change increases with its development time. Fundamentally, the design changes can be classified into pre production and post production design changes. The pre-production changes can happen in the conceptual design stage, prototype stage, detailing stage, testing stage. The post -production stage change will happen almost immediately the product is introduced into the production. This might be due to several reasons such as market response, design faults uncovering, design mistakes, not meeting customer requirements, so on and so forth. One of the tools to minimize this type of design change is House of Quality. See also * Change control * Change management (engineering) * ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Design Review
A design review is a milestone within a product development process whereby a design is evaluated against its requirements in order to verify the outcomes of previous activities and identify issues before committing to—and, if need be, to re-prioritise—further work. The ultimate design review, if successful, therefore triggers the product launch or product release. The conduct of design reviews is compulsory as part of design controls, when developing products in certain regulated contexts such as medical devices. By definition, a review must include persons who are external to the design team. Contents of a design review In order to evaluate a design against its requirements, a number of means may be considered, such as: *Physical tests. *Engineering simulations. *Examinations (Walk-through). Timing of design reviews Most formalised systems engineering processes recognise that the cost of correcting a fault increases as it progresses through the development process. Addi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
New Product Development
In business and engineering, new product development (NPD) covers the complete process of bringing a new product (business), product to market, renewing an existing product or introducing a product in a new market. A central aspect of NPD is product design, along with various business considerations. New product development is described broadly as the transformation of a market opportunity into a product available for sale. The products developed by an organisation provide the means for it to generate income. For many technology-intensive firms their approach is based on exploiting technological innovation in a rapidly changing market. The product can be tangible (something physical which one can touch) or intangible (like a service or user experience, experience), though sometimes services and other processes are distinguished from "products". NPD requires an understanding of customer needs and wants, the competitive environment, and the nature of the market. Cost, time, and qua ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Design Output
A design is a plan or specification for the construction of an object or system or for the implementation of an activity or process or the result of that plan or specification in the form of a prototype, product, or process. The verb ''to design'' expresses the process of developing a design. In some cases, the direct construction of an object without an explicit prior plan (such as in craftwork, some engineering, coding, and graphic design) may also be considered to be a design activity. The design usually has to satisfy certain goals and constraints; may take into account aesthetic, functional, economic, or socio-political considerations; and is expected to interact with a certain environment. Typical examples of designs include architectural and engineering drawings, circuit diagrams, sewing patterns and less tangible artefacts such as business process models. Designing People who produce designs are called ''designers''. The term 'designer' generally refers to someone who wor ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Voice Of The Customer
In marketing, the voice of the customer (VOC) summarizes customers' expectations, preferences and aversions. A widely used form of VOC market research produces a detailed set of customer wants and needs, organized into a hierarchical structure, and then prioritized in terms of relative importance and satisfaction with current alternatives. VOC studies typically consist of both qualitative and quantitative research steps and are generally conducted at the start of any new product, process, or service design initiative in order to better understand the customer's wants and needs, and as the key input for new product definition, Quality Function Deployment (QFD), and the setting of detailed design specifications. Much has been written about this process, and there are many possible ways to gather the information – focus groups, individual interviews, contextual inquiry, ethnographic techniques, conjoint analysis, etc. All involve a series of structured in-depth interviews, which ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
