New European Guidelines on Notified Body Surveillance Obligations Under the IVDR
The European Commission’s Medical Device Coordination Group (MDCG) has published guidance covering surveillance activities required of Notified Bodies under Article 110 of the In Vitro Diagnostic Medical Devices Regulation (IVDR).
New US FDA Guidance Covers Computer Software Assurance for Medical Device Production
The US Food and Drug Administration has published new guidance recommending appropriate risk-based computer software assurance processes related to medical device production and quality systems in order to raise device manufacturing quality levels.
New European Manual on Borderline and Classification for Medical Devices and IVDs Issued
European Commissioners have published a highly anticipated new version of the Manual on Borderline and Classification for medical devices under the Medical Devices Regulation (MDR) and for in vitro diagnostic (IVD) devices under the In Vitro Diagnostic Med
Australia Update: Medical Device UDI Implementation, Essential Principles Guidelines
The Therapeutic Goods Administration (TGA), Australia’s medical device market regulatory entity, has issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles compliance requirements and guidelines for active med
Options for Medical Device Companies to Appeal US FDA Regulatory Reviews and Decisions
FDA guidance outlines appeal options for medical device industry stakeholders disputing regulatory decisions and actions by the Center for Devices and Radiological Health (CDRH). Learn more at Emergo by UL.
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