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.
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
Address
Heiligkreuzstrasse 59,
72379 Hechingen Germany