How to develop ​software for medical ​devices?

Discover the essential aspects of planning, documenting, ​and overseeing risks during software development, while ​also maintaining regulatory compliance and safety.

Resources

Tips & best practices

Conduct regular user feedback ​sessions and usability tests ​during the development cycle

Implement agile methodologies ​in the development process to ​allow for an iterative approach

Prompt start of the ​regulatory process is key

Implement strong cybersecurity ​for customer data protection

Engage cross-functional teams ​in risk assessment workshops to ​capture diverse perspectives

Consider filing for FDA, CE ​Marking and UKCA approval in ​parallel due to process overlap