When designing and reporting studies of medical devices, manufacturers should follow established reporting checklists to ensure transparency, completeness, and compliance with regulatory and ethical standards. Reporting checklists ensure that studies of medical devices are conducted and documented in a transparent, reproducible, and standardized manner.
Various reporting checklists apply depending on the type of study (e.g., randomized trials, observational studies, systematic reviews, regulatory submissions). This White Paper explores the best reporting checklists for medical device studies (CONSORT, STROBE, STARD, PRISMA, PRISMA-DTA, SPIRIT, and TIDieR), their key components, and how they improve research transparency.
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