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.
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 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).
Implementing a medical device quality management system, or QMS, is a regulatory requirement. In the medical device industry, there is a strong focus on the regulatory requirements but a QMS should also make the organisation efficient and result in products that have high quality.
This first article in a series of three will be discussing the dangers of dividing risk management documentation according to Team NB’s recommendation. When performing risk management according to ISO 14971, a lot of medical device companies split up risk management documentation into “design risk assessment”, “process risk assessment” and “use risk assessment”. Not only is this common practice, but it is also recommended by Team NB.
What is project management for product development of medical devices? And most importantly, why should you be working with project management in the medical device industry? In this article, you will find the basic principles and practices of project
GCP is an international quality standard that governments can transpose into regulations that decide how clinical trials involving human subjects must be managed. Understanding the GCP principles allows for a successful setup and management of clinical studies and collecting data that can stand up to regulatory scrutiny.
Every stakeholder within the MDR has their own roles to fulfil, and in the medical device industry, it is of great importance to know exactly what those roles are, as is to know the difference between the stakeholders and economic operators.
In June 2020, the IEC 62366-1 standard underwent some updates – Let us look at the eight most important changes in the AMD1:2020 in order of importance.
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.