How to navigate regulations & legal frameworks?
Understanding and adhering to regulations set forth by regulatory authorities, obtaining necessary approvals or clearances, managing intellectual property rights, addressing liability issues, and ensuring compliance with relevant laws and standards.
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Resources
Tips & best
practices
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
