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Glossary Term

Agile Development

Definition

Agile Development is an iterative and incremental approach to software and product development that emphasizes collaboration, flexibility, and customer feedback. In the MedTech industry, Agile methodologies are increasingly applied to the design and development of software-driven medical devices, such as mobile health applications, wearable technologies, and Software as a Medical Device (SaMD).

Relevance to the MedTech Industry

Agile Development enables MedTech companies to adapt quickly to evolving user needs, technological advancements, and regulatory requirements. By focusing on incremental progress and continuous improvement, Agile fosters innovation and reduces time-to-market for medical devices, particularly in the fast-paced realm of digital health technologies.

Additional Information & Related Terms

  • Software as a Medical Device (SaMD) Often developed using Agile methodologies to accommodate rapid innovation.

  • ISO 62304 A standard for software lifecycle processes that aligns with Agile practices.

  • Iterative Prototyping A key component of Agile Development, enabling continuous improvement.

  • Post-Market Surveillance Supports ongoing software updates and refinements in response to real-world data.

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