NEST Data Quality Framework: A Practical Guide to Real-World Evidence (RWE) for Medical Devices
These updated versions of the Research Methods and Data Quality Frameworks incorporate NESTcc’s knowledge gained from test-cases and early NEST Mark implementations, along with the subcommittee’s extensive RWD experience. They include a broader range of data sources for quality assessment, consider recent FDA draft guidance documents, and offer additional RWE examples and best practices. They reflect the evolution in RWE innovation, aiming to provide a comprehensive resource for medical device ecosystem stakeholders.
NESTcc engaged the medical device ecosystem in a public comment period in early 2025 to gather feedback on a draft version of these Frameworks. Based on the valuable input received, NESTcc has finalized and released these updated Frameworks.
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2.0 Versions of RWE Frameworks
These updated versions of the Research Methods and Data Quality Frameworks incorporate NESTcc’s knowledge gained from test-cases and early NEST Mark implementations, along with the subcommittee’s extensive RWD experience. They include a broader range of data sources for quality assessment, consider recent FDA draft guidance documents, and offer additional RWE examples and best practices. They reflect the evolution in RWE innovation, aiming to provide a comprehensive resource for medical device ecosystem stakeholders.
NESTcc engaged the medical device ecosystem in a public comment period in early 2025 to gather feedback on a draft version of these Frameworks. Based on the valuable input received, NESTcc has finalized and released these updated Frameworks.