Creating instructions for use (IFU) for medical devices and in vitro diagnostic products requires quite a lot of responsibility.
In fact, you need to combine your techcomm skills with project management, administrative and legal skills. Luckily, what needs to be included in the instructions for use for medical devices has been determined in relevant legislation.
If there is any industry in which it is important to make sure that users can use devices safely, effectively and efficiently, it is the medical industry.
And let's not forget the importance of decreasing your liability by means of adequate instructions for use.
If you want to create a medical device user manual you need to be aware of both the content to include and the process to follow.
In this guide we are going to show you everything you need to know when creating IFU for medical devices.
We will not only show you how to create IFU for the U.S. market, but also for the European market.
And we will show you for both markets what the requirements are for medical devices as well as for in vitro medical devices.
We hope the article provides sufficient medical device instructions for use guidelines and that it gives deep insight into relevant regulation on what you have to include in your IFU, in order to meet relevant EU regulations and/or the Code of Federal Regulations (CFR) in the U.S.
Understanding and applying the requirements will help you pass Notified Body conformity assessment (in Europe) and FDA approval in the U.S.
For more details please access our link https://instrktiv.com/en/ifu-medical-devices/
