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.
Among other things, this illustrated guide provides a useful overview of quality management for medical devices and ISO 13485, clarifies terminology used in the ISO 13485 standard that is defined elsewhere, and addresses common misconceptions.
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.
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.
Most manufacturers consider the notified body conformity assessment the most challenging part of the CE marking process. This article outlines the general setup of the conformity assessment procedure for medical device manufacturers.
This article focuses on the purpose and scope of essential SOPs (Standard operating procedures) and controlling documents in a QMS. It also covers how and why you should write a thought-through purpose for your SOP or controlling document and how this impacts efficiency.
Design review is a valuable chance to stop and evaluate the situation when you are developing a medical device. Are the design requirements adequate? Is the design likely to meet these requirements? And, are there any problems that are
The new Medical Device Regulation applies to all legal manufacturers of medical devices, as well as importers and distributors of medical devices that are to be sold on the EU market. The European Commission describes the new MDR as
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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