Medical device developers often see Agile as incompatible with regulatory compliance, due to its focus on functional aspects and changing requirements. However, Agile can be adapted to meet regulatory needs and even accelerate compliance efforts. As software becomes more integral in medical devices, adopting Agile practices can address key challenges in MedTech development, balancing efficiency and regulatory demands. This white paper outlines suitable Agile practices for regulated MedTech environments.
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