Your documentation checklist for electro-medical devices
Documentation is a critical element in the regulatory review and approval process for medical devices. Yet, product development
teams often fail to understand regulatory requirements regarding documentation that are applicable to their devices- or to devote sufficient time to preparing detailed documentation covering key aspects of their product development and testing processes.
Specific documentation requirements can vary, depending on a device’s risk classification or on market-specific regulatory requirements. But there are several documentation components that are commonly applicable to all types of devices and required by the majority of regulators.
Use this checklist to evaluate your own documentation collection and preparation processes. Better yet, find ways to integrate
rigorous documentation requirements throughout the span of your organization’s product development cycle. Doing so can help
avoid unexpected surprises and costly delays in successfully bringing your medical device to market.
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