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September 30, 2025Journal of Bioengineering, Technologies and HealthOpen Access

The Importance of Validating New in vitro Medical Devices

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Authors

ACAnne CalmonGFGabriel Barreto Teles FonsecaRARui Albuquerque

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Overview

Literature review highlights the significance of validation for in vitro diagnostic devices, indicating its effects on market approval.

Key Points

  • The validation process ensures that in vitro diagnostic devices are safe and effective for public use.
  • Approval by national health authorities like ANVISA is crucial for medical devices to enter the market.
  • Health technology assessment plays a key role in evaluating the impact of validations on healthcare systems.
  • This study underscores how validated devices can minimize harm while maximizing benefits to patients.

Cite This Study

Calmon et al. (2025) studied this question.

synapsesocial.com/papers/68dc1e3b8a7d58c25ebb1a4ehttps://doi.org/10.34178/jbth.v8i3.511
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