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.

2012年 3月 23日

New Health Canada Fees Set for April 1, 2012

Canadian medical device regulator Health Canada plans to increase its fees to manufacturers starting April 1, Emergo Group’s Canada office has learned. For Class II medical device license application reviews, fees will increase from $350 to $357. For Class III medical device license application reviews, HC plans the following increases:
阅读更多
2012年 3月 19日

Guidance Released for FDA ISO 13485 Pilot Program

As part of a professed effort to align its regulatory practices more closely with those of Global Harmonization Task Force (GHTF) members, the US Food and Drug Administration is set to implement a
阅读更多
2012年 3月 15日

Neue MEDDEV Leitlinien

Der Anfang des Jahres 2012 bringt wesentliche Neuigkeiten in die Welt der Europäischen Leitlinien (MEDDEVs). Die europäische Expertengruppe für Medizinprodukte (MDEG) hat vier überarbeitete MEDDEVs freigegeben, während drei neue MEDDEV Dokumente sowie ein Leitfaden für eigenständige Softwaresysteme auf der Website der EU Kommission veröffentlicht wurden. Diese Leitfäden beschreiben übereinstimmende Positionen der EU über eine Vielzahl von Themen, die aber nicht rechtsverbindlich sind.
阅读更多
2012年 3月 15日

Nouveaux documents MEDDEV importants pour l'Europe

Le début d’année 2012 apporte des nouvelles importantes dans le monde des documents d'orientation en Europe (MEDDEV). Le groupe européen d’experts pour les dispositifs médicaux (MDEG) a publié quatre MEDDEVs révisés et a ajouté trois documents MEDDEV sur le site Web de la Commission européenne, plus un document d'orientation sur les logiciels autonomes. Ces documents d'orientation représentent des consensus dans l'UE sur une multitude de sujets, même s’ils n’engagent à rien au niveau juridique. Une brève discussion sur les principaux changements ci-dessous va s'ensuivre avec davantage de ressources.
阅读更多
2012年 3月 14日

Important New European MEDDEV Documents

The start of 2012 brings substantial news in the world of European guidance (MEDDEV) documents and one regulation. The European Medical Device Expert Group (MDEG) has released four revised MEDDEVs while adding three brand new MEDDEV documents to the EU Commission Web site, plus a guidance document on standalone software devices. These guidance documents represent EU consensus positions on a multitude of topics, though are not legally binding. A brief discussion on the major changes follows with further resources below.
阅读更多
2012年 3月 13日

Final Publication of e-IFU Regulations March 30th

Final publication of the European Commission’s regulations covering electronic instructions for
阅读更多
2012年 3月 8日

Mobile Health Sector to Reach $23 Billion by 2017

PricewaterhouseCoopers and mobile operator industry association GSMA expect global mobile health revenues to hit $23 billion by 2017, with the biggest markets in Europe and the Asia-Pacific region. A new report recently issued by the two entities, Touching lives through mobile health: Assessment of the global market opportunity , projects that European and Asia-Pacific markets will each make up 30% of global mobile health market share, followed by North America (28%), Latin America (7%) and Africa (5%).
阅读更多
2012年 3月 2日

CDRH Head: End Substantial Equivalence for Some 510(k) Applications

Center for Devices and Radiological Health (CDRH) director Jeffery Shuren has advocated rejection of 510(k) clearances in instances where applicants’ predicate devices have undergone safety recalls .
阅读更多
2012年 2月 22日

FDA Explains Electronic Study Data Submission Expectations

New guidance from the US Food and Drug Administration spells out how medical device manufacturers and study sponsors should format
阅读更多
2012年 2月 13日

Tighter EU Regulatory Controls Proposed following PIP Controversy

European Union member states should take immediate steps to
阅读更多

Pages