Tag Archives: EU MDR/IVDR

conformity

Conformity Assessment Guide: EU MDR and IVDR Compliance Strategies

By Joseph Richardson Larbi
conformity

Navigating the conformity assessment process – examination of a manufacturer’s technical documentation and quality management system – requires a thorough understanding of the different routes and options available for various risk classifications of medical devices and IVDs, while knowledge of the conformity assessment process helps manufacturers prepare effectively and manage expectations. This blog offers guidance for creating successful conformity assessments.

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