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ISO 13485 FM 546200 • ISO 14971 RM 546203 • FDA REGISTERED

Phase Gate Product Development Process

Devicix uses a 5-phase product development process as the basis for most medical device development efforts. We follow this as a guide for project planning, recognizing that each project is different and each requires a customized approach. These Development Phases and their relationship to Risk Management, Verification and Validation, and Manufacturing are shown below.

Standard Devicix medical product development process (ISO 13485 and ISO 14971 certified).

The Devicix quality management system and product development process are most often leveraged for development projects, because they provide our clients with the necessary design and documentation controls that are required for a medical device. This also affords them significant costs savings.

Phase I: Concept Phase

This phase is used to assess the technology being used for the project, and to develop any technology not currently being used in the industry or applied to the medical product being developed. Reviewing and developing the technology during this phase reduces the technical risks of the project during the development phase. It is not uncommon to develop several prototype systems before moving into medical device commercialization efforts.

Phase II: Architecture and Planning

This phase focuses on selecting the final system architecture, documenting medical product requirements, and updating the development plan. Other planning documents are prepared including a risk management plan and an associated hazard analysis.

Phase III: Design and Development

This phase focuses on completing the detailed design and drawings, and fabricating the first prototypes (engineering builds). The prototypes are tested in the lab and refinements are incorporated in preparation for the verification testing in Phase IV. With the design defined, an FMEA (Failure Modes and Effects Analysis) is completed and the design documentation is updated as needed. All test plans and protocols are completed at this point.

Phase IV: Test and Optimization

This phase focuses on completing the medical product design verification testing, the design optimization as required, and the completion of manufacturing transfer. The medical device packaging design and any regulatory testing are completed. Manufacturing transfer includes test fixtures and assistance in manufacturing process development. This phase would include any necessary clinical site selection and clinical test protocol development.

Phase V: Validation and Launch

During this portion of the project, actual manufactured units are produced and validated. Validation can consist of technical as well as market validation. This phase includes any clinical testing and FDA submission.

Project phase descriptions

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