October 20, 2020

[FEATURED] Firms With Rocky MDR Compliance Histories Shut Out Of FDA Adverse Event Program

The US agency has updated its Medical Device Reporting website with information on which products qualify for its Voluntary Malfunction Summary Reporting program for adverse events, and which don’t.

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October 13, 2020

[FEATURED ARTICLE] Requests For Additional Information During EU Audits – What To Expect And How To Avoid Them

A trend toward additional information demands from EU notified bodies risks delays and additional costs. One regulatory expert comments how the EU expectations are now closer to those in the US.

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October 5, 2020

[FEATURED] Industry Awaits Commission Ruling On Virtual Audits Under MDR

Many medtech companies are ready to demonstrate compliance with the EU MDR, but COVID-19 notified body auditing restrictions have brought their plans to a halt. The EU is trying to break the impasse.

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September 29, 2020

[FEATURED] EU IVDR: Risk Of Noncompliance Is A Real Threat Under Current Deadline Pressures

Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.

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September 22, 2020

[FEATURED] FDA Updated Its eMDR System. Here’s What You Need To Know When Submitting Adverse Events

Executive Summary

The US agency has completed planned modifications to its electronic Medical Device Reporting system – and added an extra field for MDR exemption numbers.

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