Medical device companies face a daunting set of challenges when complying with federal regulations and safety standards. Tracing and tracking the specifications needed to get products through the FDA screening process is unavoidably strict. Companies must be aware of these requirements throughout every stage of the design process if they hope to release a successful product without lengthy and costly delays and revisions.
For medical devices, ISO 14971 is the standard used worldwide for designing with safety in mind. It provides developers direction on how to assess risks while offering a framework for the most important features and functions of the device. Companies that don’t comply with the ISO standard are setting themselves up for disappointments from an FDA audit, and delays in shipping the product that often culminate in an expensive and extensive reworking of the processes, documentation, and testing.