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Get the latest global medical device regulatory news, insights from our experts and more.
Key issues regarding European MDR and IVDR compliance and implementation heading into 2023
The European Commission (EC) has named QMD Services GmbH as the eighth Notified Body designated to the In Vitro Diagnostic Regulation (IVDR).
Emergo by UL experts offer an examination of new US FDA guidance on human factors engineering (HFE) data to include in medical device regulatory submissions.
An MDCG guidance document explains the process for obtaining permission to conduct a substantial modification of a performance study in European Union member states according to Regulation (EU) 2017/746.
Recommendations for creating realistic medical device and healthcare product test environments
Our Human Factors Research & Design leader looks back on the year that was
A look at how the metaverse may affect healthcare delivery and medical product development
Innovative technologies and the need for inclusivity
An MDCG position paper explains the process for obtaining permission to sell legacy devices in European Union member states according to Article 97(1) MDR
European regulators have put forth amendments to MDR, IVDR compliance timelines to avoid medical device and IVD supply disruptions
Japanese medical device regulators have updated program codes and labeling rules.
US regulators lay out recommendations for HFE information to include in medical device registration applications
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