6661ca84bb5a51161d8e3167 Tailoring Agile Practices To Medical Device

Tailoring Agile Practices to Medical Device Development

June 12, 2024
Many medical device developers think Agile development is incompatible with regulatory compliance. However, Agile practices, when used correctly, are well-suited for highly-regulated environments and can even speed up compliance efforts.

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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