Where is Mechanical Engineering Headed? - An Overview
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Phase 0 happens outside of the design controls process, as projects often require early feasibility or concept development work prior to entering design controls. Phase 0 activities allow for rapid design iteration and verification while maintaining the critical product requirement documentation to be leveraged in subsequent project phases.
Planning that takes place at the start of the design control process will document the approach which will be followed for the duration of the project. This planning activity creates the framework (leveraging preliminary project planning document(s) developed in Phase 0) for the rest of the project, ensuring that activities, milestones, and responsibilities are clearly defined between companies and functional groups involved. A regulatory assessment may be prepared to define the product classification and regulatory strategy to help guide the development activities and will leverage any FDA feedback provided throughout pre-submission communications.
When developing a medical device, it is critical that the intended use and user needs are defined and understood. This input can be collected in a variety of ways. The user needs are then translated into measurable functional requirements to evaluate the product for performance, safety, reliability, physical attributes, etc. Later in the development process, the product design is validated to meet the user needs and the design outputs are verified to meet the design input.
Activities in Phase 3 focus on designing a product which will meet the design inputs specified in Phase 2. This effort includes extending and finalizing the prototype design through the evolution of 3D CAD models and 2D drawings, conducting risk analyses, formalizing test methods to evaluate device performance against requirements, and development of labeling and packaging. Design output documentation serves as the foundation for the DMR (Device Master Record). Design freeze occurs at the end of this phase, in preparation for design verification and validation testing.
Phase 4 may include determining appropriate manufacturing equipment and fixturing, developing process parameter settings, generating assembly work instructions and identifying critical inspections based on the output of risk analysis. Design verification and validation protocols will be written based on the requirements, acceptance criteria and test methods developed in earlier phases. Devices will be tested in accordance with these protocols. At the conclusion of this phase, a traceability matrix is generated to demonstrate that the design outputs align with the design input. Regulatory files can be compiled based on the documentation generated throughout Phases 1-4 and submitted as necessary to regulatory authorities.
Phase 5 ensures the product design is properly transferred from design into manufacturing, in preparation for commercial production. Process equipment is formally qualified (IQ/OQ/PQ), DMR documentation is transferred, and manufacturing team members are trained. A Quality Plan outlines required incoming, in-process and final product release testing necessary for production.