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Part 2 of this series of three articles investigates the dangers of dividing risk management documentation in general or according to Team NB’s recommendation. By using a heart-lung machine as an example, this article will present a comprehensive approach to risk control measures in medical device risk management.
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.
This article covers the responsibilities of the sponsor – one of the most important stakeholders in a clinical investigation. Some of the main responsibilities include The main sponsor responsibilities are: clinical quality management, communication with regulatory authorities, clinical investigation planning and conduct, and outsourcing duties and functions.
A work breakdown structure is a very useful tool for any project manager, yet many do not know what it is. This article provides an overview of how a medical device work breakdown structure (WBS) is created and its key benefits.
To achieve the purpose of the manufacturer’s PMS system, the manufacturer must have a PMS plan. This is also stated in Article 84 of the MDR. But article 84 basically only references Annex III, which is the annex that describes the requirements on the technical documentation of the PMS.
Post-market surveillance reporting requirements are different depending on the classification of the devices the PMS system covers. This article provides an overview of PMS reporting based on medical device classification.
Dealing with post-market surveillance (PMS) is important for medical devices on the EU market. It is also one of the focus areas of the notified bodies. This makes it essential for all manufacturers and others working within the medical device industry.
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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