MICHAEL SCHAEFER
Design Control
In nearly all of my roles in medical device industry I was involved in product development. For researchers and developers it is often difficult to understand the motivation, why the design process was regulated by authorities. Although there are just some basic elements in the regulation (like design input, output, verification, validation, transfer and review) it can be observed that companies are limiting their R&D teams way too far by implementing slow and complex quality procedures. It is my goal to communicate the simplicity of the design control process and to link the process with risk management and quality engineering tools.
What happens if my old devices don’t have a DHF?
ISO 13485:2016 is quite clear and a design development file (sometimes called „DHF“) is required for each medical device type or medical device family. However, in the past such file was not always established or maintained. This actually means that you will have to fill such compliance gap. There are different ways of doing it and typically I am generating a kind of executive summary for the development done in the past for that product. Get in contact with me in case you are in need for such a project. There is also a webinar available via qtec-academy.
Readability of Labeling
Several comments were made in the past with regard to simplicity in labeling, especially in Home care. Patient information (like Instructions for use) was often found to be too complex and difficult to understand for home care users. Tools are available to validate if language used in labelling is too complex or easy to understand. One tool is the “Flesch Reading Ease Test”.
Templates for Design Control
Template Design Change Request
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