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The extension of MDR implementation timeline has now become reality. On March 20, 2023, the… The post MDR Extension Timeline for Implementation appeared first on QualityMedDev.

In this post, we will delve into the key requirements outlined in Article 61 of… The post Article 61 of EU MDR: An Overview appeared first on QualityMedDev.

Article 17 of the EU MDR 2017/745 provides comprehensive guidelines regarding the requirements for the… The post Reprocess of Single Use Devices: EU MDR Requirements appeared first on QualityMedDev.

Recently, a new version of ISO 17511 has been published, bringing forth updated requirements for… The post ISO 17511: Metrological Traceability for IVD Medical Devices appeared first on QualityMedDev.

The requirements pertaining to system and procedure packs can be found in Article 22 of… The post Systems and Procedure Packs according to Article 22 of EU MDR appeared first on QualityMedDev.

The ISO 14644 family of standards serves as a comprehensive guide for establishing and maintaining… The post ISO 14644 : Requirements for Cleanrooms appeared first on QualityMedDev.

In this comprehensive article, we will delve into the requirements for Trend Reporting as outlined… The post Trend Reporting According to EU MDR and IVDR appeared first on QualityMedDev.

IEC 82304, in conjunction with IEC 62304, plays a critical role in the realm of… The post IEC 82304-1 and its Application for Stand-Alone Software appeared first on QualityMedDev.

Ancillary medicinal substances are medicinal products that are incorporated within a medical device, with the… The post Medical Devices containing Ancillary Medicinal Substances appeared first on QualityMedDev.

ISO 13485 audit is the methodology through which certification body performs the assessment of a… The post ISO 13485 Audit appeared first on QualityMedDev.