Hogan Lovells wrote on 7 FEB ’11 an excellent summary on the situation and status of where the EU is in relation to Collective Redress including a consultation paper that was issued by the EU Commission.
Leo Eisner Presenting at RAPS/ASQ on IEC60601-1 3rd ed.
Biomedical Division Northern California Discussion Group andSan Francisco Bay Area Chapter Topic: “Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas: IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration,
EU Interpretative Doc on Placing Med Dev’s on Mrkt
On 16 November 2010 this Interpretative Document was issued to explain what is considered Placing Medical Devices on the EU Market. The document refers to all 3 medical device directives including the amendment 2007/47/EC. The 3 medical device directives this
Are You Using The Proper Version of EN 60950-1?
Thank you NEMKO for this article: The standard for IT-equipment, for the EU is EN 60950-1:2006, and it was amended with A11 in 2008, with DOP (Date of Publication) 1 December 2009. The A11 is a European amendment only, with
Eucomed requests improvements in EU Notified Body Based System
26 Oct 2010 From ‘MTB europe – Technology for healthcare’ Eucomed calls for improvements in EU Notified Body based system http://www.mtbeurope.info/news/2010/1010051.htm