Software/apps in healthcare: basics for medical device beginners

Description
This course is specially designed for startups and newcomers to the medical device industry.

Content/ The following questions will be answered:

• Is my product/my software really a medical device (MP)? Answer demarcation questions correctly
• What is the purpose and what are the strategic implications?
• From a legal point of view, what does an MP manufacturer/distributor have to do with it?
• What does a typical product life cycle of an MP look like and what needs to be considered?
• How do I clear the hurdle of clinical data (framework conditions for (pre)clinical studies, etc.)? References versus the need for a clinical study?
• Typical pit falls

Set
Startups and newcomers to the medical device industry are given all the necessary questions that should be asked when introducing a medical device.