This article outlines key competencies necessary for internal auditing, the importance of training and certification, and offers guidance on selecting the right courses to become a certified internal auditor.
Effective planning is a cornerstone of any successful internal audit, and one essential tool that auditors often rely on is an internal audit checklist.
This article breaks down what an audit checklist is, if it is required, best practices, and tips for avoiding common pitfalls.
What is remote auditing? Simply put, it refers to conducting audits using remote auditing methods. These methods offer distinct advantages, such as time and cost savings, but they also come with unique challenges.
This article explores key considerations for conducting an efficient “remote audit” using remote auditing methods and provides insights into the preparation, technology use, and common obstacles involved in remote auditing.
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).
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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