AJAX progress indicator
  • A document used to describe how the new product will be developed and includes elements such as key activities, responsibilities, timing, interfaces between different groups. Read More
  • Deductive reasoning is based on the logic that if something is true for a class of things, it is also true for all members of that class ii (top-down). The investigator starts with a theory and makes predictions based on the theory. Controlled experiments are used to determine whether the(...) Read More
  • The degree of risk is a measurement of risk along a continuum. One end represents no possibility of loss or opportunity (either the probability of occurrence has been eliminated, or we have found a way to circumvent the issue should it occur). The other end represents risks that cannot be(...) Read More
  • Measurement of uncertainty along a continuum. One end represents uncertainties that are resolved (made certain or close enough). The other end represents uncertainties, where obtaining the facts is impossible or too expensive. Example: High uncertainty exists if a company sees an(...) Read More
  • A document used to describe how the new product will be developed and includes elements such as key activities, responsibilities, timing, interfaces between different groups. Read More
  • Any change to the product or manufacturing process design. In Medical Devices, these changes include evolutionary changes such as performance enhancements as well as revolutionary changes such as corrective actions resulting from the analysis of failed product. Read More
  • Set of requirements related to medical device product development and product changes. The requirements are based on good engineering product development processes, product maintenance, and project management processes. The application of design controls to any product may be adjusted based(...) Read More
  • The process of proactively designing products to (1) optimize all the manufacturing functions: fabrication, assembly, test, procurement, shipping, delivery, service, and repair, and (2) assure the best cost, quality, reliability, regulatory compliance, safety, time-to-market, and customer(...) Read More
  • The point in product development when the design is considered ‘done’ and the design is captured as a baseline. In medical devices, changes to the design after this point are tracked and evaluated for impact to meeting intended use, design inputs, and risk management controls. Read More
  • A compilation of the records describing the entire history of the medical device design. It begins prior to development, is maintained through the product life, and includes design documents plus product change documents. Read More
  • The documented product requirements which are used as the basis for the device design. Design inputs are developed by translating the customer needs and requirements into product requirements. Read More
  • The documented results of the design effort which enables verification against the design inputs. FDA: The total finished design output consists of the device, its packaging and labeling, and the device master record. ISO: The final version will include the product requirements used for(...) Read More
  • A documented systematic review of the design. From the FDA’s perspective this should be a system level review and include a review of many key functions within the project based on where the project is in development. Read More
  • Translation of device design to production specifications to ensure the product can be reliably and reproducibly manufactured, and which meets the design safety and efficacy. Read More
  • Documented, objective evidence that the design meets the user needs and the intended use. Read More
  • Documented objective evidence that the design meets the design requirements. Read More
  • A compilation of records containing the procedures and specifications (such as BOM, drawings, manufacturing instructions) for a finished device. Read More
  • Diffusion is defined by Everett Rogers as the process by which an innovation is communicated through certain channels over time among the members of a social system. Some people take longer than others to try out and adopt a new innovation. Read More
  • This is one of the earliest stages in the new product development process. Activities during Discovery include a high level investigation and description of the idea. The description should include an overview of the idea, the problem it will solve, strengths and weaknesses of the idea and(...) Read More

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