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A woman wearing a coat, a hat and sunglasses, standing in front of a desk with a locked file on it. Symbolizing trade secrets . A woman wearing a coat, a hat and sunglasses, standing in front of a desk with a locked file on it. Symbolizing trade secrets .
Regulatory Affairs - Updated: 2021/04/16 - 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!

Silhouette of a doctor, the head filled with bits and a chip, symbolizing artificial intelligence in medicine . Silhouette of a doctor, the head filled with bits and a chip, symbolizing artificial intelligence in medicine .
2019/05/02 - Artificial Intelligence - Updated: 2021/04/16 - 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.

A folder with the elements lock (=cybersecurity), law, workflows, GDPR, Data and UDI floating into it, symbolizing Technical Documentation A folder with the elements lock (=cybersecurity), law, workflows, GDPR, Data and UDI floating into it, symbolizing Technical Documentation
2019/04/17 - Technical Documentation - 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 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 . 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 .
2019/04/04 - Cybersecurity - 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.

Opening Doors, a sign with the US flag and the word "Store", inbetween the opening doors a cd with sparkles, symbolizing US Market Access Opening Doors, a sign with the US flag and the word "Store", inbetween the opening doors a cd with sparkles, symbolizing US Market Access
Medical Software - Updated: 2021/04/16 - Thorsten Prinz and Tobias Schreiegg

Market Access for Medical Software in the United States

Market access of medical software in the U.S. is quite different compared to Europe. Get insights about the principles.

In the foreground a hand above a red button, in the background an MRI with some bolts around it, symbolizing dangerous error condition. The whole image symbolizes Risk Management for Medical Devices. In the foreground a hand above a red button, in the background an MRI with some bolts around it, symbolizing dangerous error condition. The whole image symbolizes Risk Management for Medical Devices.
2019/03/04 - Risk Management - Hans Wenner

Risk Management for Medical Devices

Risk management in medical devices is an important contribution to patient safety. But how do you perform a risk management. We tell you!

A monitor showing white outlines of a brain on a black background, symbolizing Medical Imaging A monitor showing white outlines of a brain on a black background, symbolizing Medical Imaging
2019/02/19 - Case Study - Mortimer Gierthmühlen

Medical Imaging Software – What Clinicians need

Medical imaging software is developed for clinicians. Do you know what requirements these professional users have? Here a user tells you!

A shield in with a lock on it in the foreground, 0 and 1 in the background, symbolizing cybersecurity principles in software A shield in with a lock on it in the foreground, 0 and 1 in the background, symbolizing cybersecurity principles in software
2019/02/05 - Cybersecurity - Updated: 2021/04/16 - Thorsten Prinz and Daniel Jacobi

Cyber Security Threats in Healthcare

Cyber security threats affect medical device safety and patient protection. Learn here how to perform best regarding risk management.

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