Compliance

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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Tips & best

practices

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Get user feedback ​regularly

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

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Use agile ​methodologies

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

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Assess risks

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

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Start the ​regulatory ​process promptly

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