Week 1 Flashcards
intended use
general purpose of the device or its function
indications for use
more detail, describes the disease/condition the device will treat, mitigate, prevent, cure, diagnose, including a description of the patient population.
biocompatible
ability of a material to perform with an appropriate host response in a specific application
Product Development Timeline
- concept - early VOC
- feasibility
- development - prove safety and efficacy, clinical VOC
- integration
- base business
- product retirement
Pipeline Funnel
company’s 5-10 year plan for business spending and sales profit
Documentation Control allows for:
complete traceability of design and manufacturing decisions in the event of adverse occurrence during the design and development process or during production post launch.
Product Requirements
include the needs of the users/patients and addresses the intended use of the device
Product Specifications
typically covers the details of the product requirements
Design Specifications
document that is derived from the Product Specifications; Requirements found in the Product Specification are partitioned to specific design requirements for each subassembly
Design Verification
performed to confirm that the design output meets the design input requirements
Design Validation
performed to ensure that the device conforms to user needs and intended users
Design Inputs
are the physical performance characteristics of a device that are used as a basis for the device design
Design Outputs
everything produced during the Design and Development Process; all documentation
Design History File (DHF)
contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plans and the requirements of the Quality Systems Regulation
House of Quality
part of the Quality Function Deployment (QFD); methodology to help focus on product/service characteristics from the view points of market-segment, internal, or technology-development needs.
