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Showing posts tagged with: Regulatory Compliance

Cup of Joe 36# - Scary word “Audit”

Cup of Joe 36# - Scary word “Audit”

An Audit is the on-site verification activity of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step. A system audit also delivers objective evidence concerning the need for a reduction, elimination and most importantly, prevention of...
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Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix

Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix

An effective traceability process is an essential requirement when developing medical device software and achieving regulatory compliance. How to create a Traceability Matrix? Traceability Matrix can be very difficult to create. It can take months to put together manually, especially without a proper tool. Creating and maintaining a TM can be time-consuming and difficult, not to mention all...
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