This article explores what key stakeholders need from your software development process and how you can meet those needs effectively while still embracing the principles of the Manifesto for Agile Software Development and guidance from AAMI TIR45 by using an Agile software development process.
This article covers what ’ready’ and ’done’ really mean in Agile development practices and why clear definitions are especially critical in medical device software development where compliance and traceability matter.
In this article, auditing expert Peter Sebelius walks through real-world audit scenarios and audit findings, demonstrating how to reference requirements correctly and avoid common pitfalls—such as making assumptions or drawing subjective conclusions.
This article will provide an overview of the internal audit process in the medical device industry, covering essential audit terminology such as audit program, conformity and audit findings.
E-learning and AI will play a big part in the future of learning solutions, but one thing is for sure: Learning will never go back to only traditional classroom courses.
At Medical Device HQ, we have seen better results and happier course participants since we took a step away from traditional classroom courses.
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.
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.
Special launch offer: 349 299 EUR for the online plan & 449 349 EUR for the online lifetime plan.