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.

2007年 1月 1日

EU releases new guidance document for e-labeling

A new guidance document has been released that deals with the issue of e-labeling.
2007年 2月 1日

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

Bulgaria and Romania joined the European Union on 1 January 2007.
2007年 4月 1日

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
2007年 6月 12日

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.
2007年 9月 1日

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.
2007年 10月 12日

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.
2008年 2月 27日

Medical Device Clinical Evidence Requirements: Are You Prepared?

Article discusses the changing requirements for clinical evidence for medical devices marketed in Europe.
2008年 3月 1日

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
2008年 3月 28日

New Year, New Details of European Regulatory Changes Ahead

This article first appeared in Medical Products Outsourcing in January 2012. Regarding revisions to the...
2008年 5月 8日

Are you considered a medical device manufacturer?

It's no secret that today's medical device manufacturers are a diverse lot that exist in...