Tag Archives: QMS

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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Wiktoria Banczyk
MEDdesign

Ask the Expert: The Impact of IVD Regulations on Manufacturing

Wiktoria Banczyk

IVDR has significant implications for the manufacturing of IVD devices, as it requires manufacturers to comply with new and more rigorous regulatory requirements. Wiktoria Banczyk, Product Manager Lab Filtration Medical Devices at Sartorius Lab Instruments, discusses the challenges posed by the implementation of EU IVDR 2017/746 and key considerations for manufacturers as they navigate today’s regulatory landscape.

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