Maintaining a validated state for your manufacturing processes is crucial to ensure product quality and regulatory compliance.
This article discusses when processes need to be revalidated and when certain validation steps could potentially be skipped.
This article discusses when process validation needs to be performed, both during the development of a medical device and in production. It also highlights the importance of validating manufacturing processes after changes to equipment, design, or production environments.
This article lists key documents and in process validation for medical devices, including the master validation plan (MVP), user requirement specification (URS), and various qualification protocols (IQ, OQ, and PQ).
Process validation is crucial when manufacturing medical devices, especially where the quality and safety of the final product cannot be fully verified without destructive testing.
This article covers the necessary regulations, standards, and guidelines related to process validation of medical devices in the US and the EU.
This illustrated guide will provide a useful overview of risk management and ISO 14971; and address common misconceptions within risk management.
This guide will break down the regulatory terms and help you understand SaMD and the IEC 82304-1 standard. It discusses AI, ML, continuous integration and continuous deployment (CI/CD) when developing software as a medical device (SaMD).
This illustrated guide provides a useful overview of IEC 62304, clarifies terminology used in the standard, and addresses common misconceptions in medical device software development.
Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course.
These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.
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