Navigate quality management essentials in our illustrated guide, now as an ebook!

Medical device design control terminology feature image

Medical device design control terminology

When you are presented with a medical device product development project, you do not want to have to ask what the intended use, user needs, design input, design verification, and design validation means. You will learn about this and

What is a medical device? feature image

What is a medical device?

There are numerous requirements by the competent authorities and notified bodies that medical device manufacturers have to follow. But there is a catch: what exactly is considered to be a medical device? Bear in mind that the article covers only the

How to perform medical device design review feature image

How to perform a medical device design review

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

How to Write Instructions For Use For Medical Devices feature image

How to write instructions for use for medical devices

The instructions for use is not only something which is referred to in many ways, such as user guide, operating manual or labelling. It is also a document which can be instrumental in achieving safety for a medical device.

Recent Posts
Would you like to learn more about risk management or design control?

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.

Get in touch to receive proposal for customised training

When you submit this form, your personal data will be processed in accordance with our privacy policy.