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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
Maven

Quantification of Benefit – Risk Analysis

Clinical Development Plan
Oct 11, 2022
Maven

Clinical Development Plan (CDP)

Medica device manufacturing
Oct 3, 2022
Maven

Identification and Traceability in Medical Device Industry

Medical Device
Aug 29, 2022
Maven

Verification Versus Validation of Processes in Manufacturing Medical Devices

Risk Management
Aug 22, 2022
Maven

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
Maven

Correction Corrective Action and Preventive Action

Medical Device Industry Maven
May 6, 2022
Maven

Evolving Role of Regulatory Affairs in Medical Device Industry

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Recent Post

EU MDR for Medical Devices
April 16th, 2025

Preparing for 2025: Key Challenges under EU MDR for Medical Device Manufacturers
Role of IEC 62304 in Streamlining 510(k)
April 9th, 2025

The Role of IEC 62304 in Streamlining 510(k) Submissions for Medical Device Software
EU MDR Regulation
April 2nd, 2025

How to Align with FDA Compliance and EU MDR Regulation for Global Medical Device Launches?

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