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Global Medical Device News

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Medical Device Risk Management and Risk Analysis Using ISO 14971:2012

This article discusses ISO 14971:2012 and its application to medical device and IVD manufacturers.

Source | support
May 8, 2008
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Are you considered a medical device manufacturer?

It's no secret that today's medical device manufacturers are a diverse lot that exist in many different shapes and sizes. Previous articles have described products that are medical devices in Europe; however, have you ever considered if your organization actually falls into the defined terms of what is considered a "manufacturer" in Europe and how some of your relationships might expedite the 

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Source | Stewart Eisenhart
May 8, 2008
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New Year, New Details of European Regulatory Changes Ahead

This article first appeared in Medical Products Outsourcing in January 2012.

Regarding revisions to the European Union’s medical device regulations, 2012 is off to a vigorous start. As the new year begins to take shape, it would be constructive to both highlight major EU regulatory developments occurring in 2011 as well as identify major issues likely to impact the European medical device market in 2012.

The year that Was: 2011 Events and the Future of EU RegulationThe major European medical device regulatory developments of 2011...

Source | Stewart Eisenhart
Mar 28, 2008
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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

Source | Stewart Eisenhart
Mar 1, 2008
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Medical Device Clinical Evidence Requirements: Are You Prepared?

Article discusses the changing requirements for clinical evidence for medical devices marketed in Europe.

Source | support
Feb 27, 2008
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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.

Source | Stewart Eisenhart
Oct 12, 2007
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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.

Source | Stewart Eisenhart
Sep 1, 2007
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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.

Source | Stewart Eisenhart
Jun 12, 2007
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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

Source | Stewart Eisenhart
Apr 1, 2007
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Bulgaria and Romania admission to the EU and impact for medical device manufacturers

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

Source | Stewart Eisenhart
Feb 1, 2007