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Team NB Position Paper Submission of Technical Documentation Highlights

Mar 16, 2023 | News

On February 25, 2023, Team-NB issued a position paper titled Best Practice Guidance for the Submission of Technical Documentation under Annex II Technical Documentation and Annex III Technical Documentation for Post-Market Surveillance of EU In Vitro Diagnostic...

Understanding FDA’s New Guidance Document on Human Factors Information in Medical Device Submissions

Jan 18, 2023 | News

Human Factors Engineering is a crucial part of ensuring the safety and effectiveness of medical devices. Human factors testing is valuable when designing device/user interfaces. To help manufacturers understand the extent of human factors (HF) information required in...

Understanding FDA’s Draft Guidance Document on Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

Jan 13, 2023 | News

Medical device reporting (MDR) is an important post-market activity that helps to ensure patient safety. The FDA receives over two million medical device reports annually, with malfunctions accounting for most reports received. The Voluntary Malfunction Summary...

European Union Clinical Trials Regulation: Mandatory Deadline Approaching

Dec 20, 2022 | News

Since 2004, clinical trials in the EU have been controlled by the European Union Clinical Trials Directive (EU-CTD). The directive was an attempt to standardize rules and enhance patient protections in clinical trials; however, its real-life implementation created...

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