Regulatory update: How to stay up to date with regulatory requirements

Manufacturers of medical devices, as well as manufacturers in all other life science sectors, such as the pharmaceutical industry, are required to carry out a regular “regulatory update.” Because as strange as it sounds, regulatory requirements oblige manufacturers to continuously monitor and evaluate changes to regulatory requirements and take any necessary measures. Keeping track of…

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Abnormal use or foreseeable misuse?

Medical device and IVD manufacturers must distinguish the concepts of “abnormal use,” “foreseeable misuse,” “errors in normal use,” and “misuse.” This is a prerequisite for understanding and complying with ISO 14971 and IEC 62366 requirements. Even the measures that manufacturers must take depend on the type of use.

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