Medical Device Development
Slide 4: The listed post-production medical device life-cycle stages are aligned with the examples listed under the ISO 14971:2019 definition of post-production.
Slides 4-5: In the context of life-cycles, the terms stage and phase are interchangeable. To reduce confusion, AganaMed uses stage when referring to individual medical device life-cycle stages and phase when referring to a company’s (manufacturer’s) product development life-cycle phases.
Slide 5: As shown on the diagram on the right, for product development life-cycle phases, “product launch” is a fixed milestone in time. If a company (manufacturer) chooses to conduct a pre-launch stock build (in anticipation of a sales spike soon after product launch), the stock build is either included in the Validation phase or the Validation phase is subdivided to include a Stock Build mini-phase prior to product launch.
Slide 5: [Note: The following esoteric clarification is intended for experienced medical device developers only.] On the diagram of individual medical device life-cycle stages on the left, “product launch” is not shown because the location of product launch (with respect to the diagram) can vary depending on the circumstances of the specific medical device unit under consideration. For example, for a medical device unit that does not include any post-production product design changes and that was not produced either during a successful pre-launch process validation build (sometimes known as a “pilot build” of initial production units) or during a pre-launch stock build, product launch occurs between the Development and Production life-cycle stages. On the other hand, for a medical device unit that does not include any post-production product design changes and that was produced during either a successful pre-launch process validation build or during a pre-launch stock build, product launch occurs between the Production and Delivery life-cycle stages. For a medical device unit that does include any post-production product design changes, product launch occurs during the Development life-cycle stage.
Slide 10: The clinical terms performance evaluation and performance study pertain to in vitro diagnostic (IVD) medical devices.
Slide 15: The Quality Management System (QMS) standard ISO 13485:2016 is available for purchase on the ISO website.
Slide 15: The US Quality System Regulation (QSR) FDA 21CFR820 is available for free on the e-CFR website.
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