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Expert Insights on Medical Device
Business and Compliance

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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

The Evolving Role of Regulatory Affairs in the Medical Device Industry

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Recent Post

EUDAMED
March 2nd, 2026

EUDAMED Mandatory from 28 May 2026: What MDR and IVDR Manufacturers Must Do Now
Biocompatibility Testing for Medical Devices
February 28th, 2026

Cytotoxicity Testing: The First Step in Biocompatibility Testing for Medical Devices
Red Flags in Clinical Evaluation
February 14th, 2026

When Literature Review Isn’t Enough: Regulatory Red Flags in Clinical Evaluation

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