As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

May ,24 2019

US FDA calls for test cases for its SaMD Pre-Cert Program

The US Food and Drug Administration has called for test
May ,08 2008

Are you considered a medical device manufacturer?

It's no secret that today's medical device manufacturers are a
Mar ,28 2008

New Year, New Details of European Regulatory Changes Ahead

This article first appeared in Medical Products Outsourcing in January
Mar ,01 2008

Proposed Changes to the GHTF Regulatory Auditing Guideline

Upcoming changes to QMS auditing requirements have been proposed by Study Group 4 of the Global Harmonization Task Force (GHTF.) These changes may affect your company and you have until 14 MAY 2008
Feb ,27 2008

Medical Device Clinical Evidence Requirements: Are You Prepared?

Article discusses the changing requirements for clinical evidence for medical devices marketed in Europe.
Oct ,12 2007

Upcoming Changes to the European Medical Device Directive

Recently, we told you about a new Directive (2007/47/EC) that will affect all manufacturers selling medical devices in Europe.
Sep ,01 2007

Amendments to the European Medical Device Directives published

The European Commission has officially adopted a new Directive that is of critical importance to most medical device companies selling and/or conducting clinical trials in Europe.
Jun ,12 2007

Europe issues new guidance document on medical device post market surveillance and vigilance.

The European Commission has issued a revised version of MEDDEV 2.12-1 which provides guidance to industry and Competent Authorities on how to meet the medical devices vigilance system requirements.
Apr ,01 2007

Hip, knee and shoulder reclassification

Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices was issued in August 2005, at th
Feb ,01 2007

Bulgaria and Romania admission to the EU and impact for medical device manufacturers

Bulgaria and Romania joined the European Union on 1 January 2007.

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