This is an excerpt from the course "Clinical Investigation for Medical Devices and ISO 14155."

This is an excerpt from the course "Introduction to SaMD, IED 62304 and IEC 82304-1."

This is an excerpt from the course "Introduction to the Medical Device Regulation (EU) 2017/745"

This is an excerpt from the course "Clinical Investigation for Medical Devices and ISO 14155."

Ever had problems with compliance to IEC 62304? Do you want to apply Agile development principles such as SCRUM when working with medical device software? No problem! In this video, Christian Kaestner will explain how you can work the way you want and document how it is compliant with IEC 62304.

This is an excerpt from the course "Introduction to Usability engineering and IEC 62366-1"

This is an excerpt from the course "Usability Engineering and IEC 62366-1."

This is an excerpt from the course "Introduction to the Medical Device Regulation (EU) 2017/745."

This is an excerpt from the course "Introduction to the Medical Device Regulation (EU) 2017/745."

This is an excerpt from the course "Introduction to the Medical Device Regulation (EU) 2017/745"

This is an excerpt from the course "Clinical Investigation for Medical Devices and ISO 14155."

This is an excerpt from the course "Introduction to the Medical Device Regulation (EU) 2017/745."

This is an excerpt from the course "Introduction to the Medical Device Regulation (EU) 2017/745."

This is an excerpt from the course "Introduction to Risk Management for Medical Devices and ISO 14971:2019."

Medical device software risk management can be a challenge! In this video, you will not only learn about the difference between “software risk control” and “risk control measures implemented by software”, you will also learn about where to look for potential software causes contributing to hazardous situations. And finally, how to document software risks, causes and measures.

This is an excerpt from the course "Clinical Investigation for Medical Devices and ISO 14155."

Are you struggling with the terms software unit, item, and system in IEC 62304? In this video, the “Brickman” will assist me in explaining these essential terms when developing medical device software.

This is an excerpt from the course "Introduction to the Medical Device Regulation (EU) 2017/745."

This is an excerpt from the course "Clinical Investigation for Medical Devices and ISO 14155."

It is common to leverage existing software components in medical device software, such as open-source libraries. Software you do not develop yourself is called OTS, Off-The-Shelf, software or SOUP which stands for Software of Unknown Provenance.