Medical Device Software: ​Software Lifecycle Processes ​(ISO/IEC 62304)

International Organization for ​Standardization

MedTech Europe - Guidance ​on Medical Device Software ​Development and Qualification

MedTech Europe

Software as a Medical Device: ​Possible Framework for Risk ​Categorization and ​Corresponding Considerations

International Medical Device ​Regulators Forum

Guidance on the Use of AGILE ​Practices in the Development of ​Medical Device Software

Association for the Advancement of ​Medical Instrumentation

Cybersecurity in Medical ​Devices: Quality System ​Considerations and Content of ​Premarket Submissions

FDA

Medical Device Cybersecurity: ​What You Need to Know

FDA

FDA General Principles of ​Software Validation

FDA

Software as a Medical Device ​(SaMD): Clinical Evaluation

FDA

Get user feedback ​regularly

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

Use agile ​methodologies

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

Assess risks

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

Start the ​regulatory ​process promptly

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

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