Medical Software, Workshop - Online Event on October 5th, 2021

Agile Development of Medical Software

Is it true that an agile approach to software development for software that is a medical device cannot be used in compliance with the MDR? The answer is: “No. This is not true.”
Find out more in our online workshop.

Head with Gear Wheels symbolizing AI (Artificial Intelligence) Head with Gear Wheels symbolizing AI (Artificial Intelligence)
Artificial Intelligence, Workshop - Online Event on June 22, 2021

Regulatory Affairs for AI Applications in Medical Devices

The use of AI blurs the determination of classic software products because the training data alters the algorithm. Hence, all stakeholders are facing new challenges: the potentially continuing modifications as well as being very much depended on carefully selected training data. Therefore, currently AI algorithms need to be implemented in a frozen state in medical devices to receive clearance for US or EU market access.

A smartphone showing the symbols of a microphone, a loudspeaker and a voice recognition software. On the left hand a speech bubble out of face silhouette, on the right side a speech bubble from the smartphone app. Symbolizing increased patient compliance for patient diaries for telemonitoring through speech recognition. A smartphone showing the symbols of a microphone, a loudspeaker and a voice recognition software. On the left hand a speech bubble out of face silhouette, on the right side a speech bubble from the smartphone app. Symbolizing increased patient compliance for patient diaries for telemonitoring through speech recognition.

Improving Patient Compliance With Speech Recognition

The use of patient diaries for telemonitoring often fails due to a lack of compliance. The use of speech recognition can increase patient compliance.

A hand with a red hose leading to a blood icon, a hand with a smart phone and a diagram and a certificate saying "compliance". Symbolizing MDR compliance for medical apps. A hand with a red hose leading to a blood icon, a hand with a smart phone and a diagram and a certificate saying "compliance". Symbolizing MDR compliance for medical apps.

[Video] How to Achieve MDR Compliance for Medical Apps

It’s hard to achieve MDR compliance when developing medical apps. Learn in this presentation how to overcome this hurdle.

A folder with a star on it, containing one document, symbolizing Best Practices in Software Documentation. A folder with a star on it, containing one document, symbolizing Best Practices in Software Documentation.
2019/02/04 - Medical Software

Software Documentation: Best Practices

Software documentation can meet regulatory requirements although it is based on an agile development process. Our video will show you how!

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