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Expert Insights on Medical Device
Business and Compliance

  2. Tag
Medical Device Regulation MDR
May 19, 2023
Maven

EN ISO 14971:2019/A11:2021 and EU MDR/IVDR Safety & Performance Requirements

EU IVDR Regulation
Dec 15, 2022
Maven

European Commission Considers Extending MDR and IVDR Deadlines

EU MDR 2017
Nov 29, 2022
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Quantification of Benefit – Risk Analysis

Clinical Development Plan
Oct 11, 2022
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Clinical Development Plan (CDP)

Medica device manufacturing
Oct 3, 2022
Maven

Identification and Traceability in Medical Device Industry

Medical Device
Aug 29, 2022
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Verification Versus Validation of Processes in Manufacturing Medical Devices

Risk Management
Aug 22, 2022
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Residual Risk: How to Evaluate it?

In Vitro Diagnostic (IVD)
Jun 16, 2022
Maven

Is Your Product Legacy Certified or Self-Certified under IVDD? What You Need to Know!

correction-outer
May 17, 2022
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Correction, Corrective Action, and Preventive Action

Medical Device Industry Maven
May 6, 2022
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The Evolving Role of Regulatory Affairs in the Medical Device Industry

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