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Medical Device Contract Engineering
Engagement Process
Devicix provides medical device contract engineering services. The engagement process with Devicix is a simple and effective process that helps our clients understand the timeline and costs associated with developing medical products. The outcome from this process alone adds significant value to our clients because it creates a detailed schedule that forms the basis for the client's project plan required as part of the design controls in medical product development.
The project proposal is a key document that we create to identify and communicate the expected scope and duration of a medical product development project. A set of initial meetings give us the opportunity to meet with our clients to gain an understanding of their needs, and their medical product or technology. We then create a detailed project plan. A "bottoms-up" schedule and cost assessment provide the detail necessary to truly understand and communicate the medical product development effort, requirements, deliverables and uncertainties. This project schedule also becomes the basis for the formal project plan that is created as part of the design controls required for the development of a medical device.
The final proposal includes this schedule and descriptions of the outlined work tasks. Work plans range from specific tasks needed to solve a production or field issue, to the tasks needed to take an idea from a napkin sketch through market release, including all the required regulatory, mechanical, electrical and software verification and validation efforts. Devicix's medical product development process follows a "phase gate" product development process. This process is described on our Phase Gate Product Development Process page.
