A woman wearing a coat, a hat and sunglasses, standing in front of a desk with a locked file on it. Symbolizing trade secrets .
Published: 2019/05/16 - Law - Updated: 2019/06/07 - by Janine Manke and Daniel Kendziur

Trade Secrets: Protect Your Intellectual Property

You must understand the importance of protecting your trade secrets or the development of your medical software was useless!

Picture with 4 parts, all connected by circular arrows. First part showing a person thinking of a CD, symbolizing the idea generation. Second part showing a smoking enterprise and a CD with sparkling stars, symbolizing development and production of the software. Third part is the CD with sparkling stars in a shopping cart, symbolizing the marketing of the product. Fourth part shows crossed wrenches, symbolizing maintenance. All together symbolizing software life cycle .

Software Life Cycle: How do I meet the Regulatory Requirements?

Development of medical software must follow the life cycle principles. Learn in our workshop how to implement the respective standards.

Silhouette of a doctor, the head filled with bits and a chip, symbolizing artificial intelligence in medicine .
Published: 2019/05/02 - Guidance - Updated: 2019/07/08 - by Thorsten Prinz

Market Access for Artificial Intelligence in Medicine

How does current regulation for market access fit with artificial intelligence in medicine? Find out more by a practical example.

In the foreground a cloud with bubbles in it, showing a smart phone, a monitor, a heart with a an ecg symbol on it, an x-ray-image, and a brain with lighting dots, symbolizing cloud data.

Secure Cloud Use in Healthcare

Due to the particularity of health data cloud use in healthcare can be difficult. Learn more about cloud, health data and IT in our workshop.

A folder with the elements lock (=cybersecurity), law, workflows, GDPR, Data and UDI floating into it, symbolizing Technical Documentation
Published: 2019/04/17 - Guidance - by Thorsten Prinz

Technical Documentation: See the Opportunities, not the Challenges!

The technical documentation of medical devices in the EU must be revised. We tell you what to keep an eye on and how to make it a success!

A billboard in the background advertising a medical devise, two hands, one handling a production idea, the other one handing over a sack of money. Symbolizing added value and reimbursement.

Added Value in Medical Technology

The manufacturer must demonstrate the relevant facts about benefits, added value and referencing. Find out more in our workshop.

A person working on a computer, Numbers 1 and 0 floating into a green lock, in the background a medical examination table and an American flag, in the foreground a medical kit; symbolizing healthcare cybersecurity .
Published: 2019/04/04 - Guidance - by Axel Wirth

Healthcare Cybersecurity – the U.S. Perspective

Healthcare cybersecurity in the U.S. encounters basically the same threats as everywhere but unique challenges apply as well.

A lamp, a doctor and a a lying man, seeing his brain, symbolizing neurosurgery

In-Clinic Workshop “Neurosurgery for Engineers”

Learn from neurosurgery doctors what their challenges and expectations are concerning medical devices in the clinical environment.

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