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Update to BSI White Paper on Proposed EU Regulations for Medical Devices & IVD’s

BSI recently updated the white paper on Proposed EU Regulations for Medical Devices & IVD’s to reflect the latest EU vote in early April, enabling the commission to move forward with the legislation.

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BSI White Paper on Proposed EU Regulations for Medical Devices & IVD’s

This article focuses on BSI’s new White Paper Series for the Medical Devices & IVD’s industries, First one on the EU Proposed Regulations 9 April 2014 – Today marks the beginning of a series of white papers that BSI has just released.   White Paper on Proposed EU Regulations This initial white paper is on [...]

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MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012″

7 March 2014 – MD&DI article written by Leo Eisner of Eisner Safety Consultants about the confusion of the EU Harmonized Standard EN ISO 14971:2012 Annexes ZA, ZB, & ZC that amends the EN ISO 14971:2009 version of the standard to align with the 3 Medical Devices Directives (the Medical Device, Active Implantable Medical Device, [...]

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NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation

On Tuesday Feb 11, 2014 at the UBM Canon Communications MD&M West Conference Leo Eisner of Eisner Safety Consultants presented this material as the Track Chair for “Improving Risk Management Strategies And Procedures”.  He spoke on the proposed Consensus Guidance Document on EN ISO 14971:2012 that is currently being drafted by NBRG (the Notified Body Recommendation [...]

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NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012

This post discusses NBRG’s call to participate in an Industry Survey on Industry’s Practice of Risk Management Process per EN ISO 14971:2012. On 7 February 2014 the Vice Chair of the Notified Body Recommendation Group, Michael Bothe, sent out a letter to industry to ask for their participation in a short survey (about 10 minutes long) [...]