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COMMISSION IMPLEMENTATION DECISION M/575 was issued 14 April 2021: This is a list of standards the EU Commission is hoping to Harmonize under MDR and IVDR. One of the issues is the HAS consultant has issued a negative assessment on
We strive at Eisner Safety Consultants (ESC) to provide the best services for our clients and we have found one that is ideal for many of our small to mid size medical device companies we work with. greenlight.guru produces
Just released as of June 25, 2014 this NBRG Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971:2012 is finally available. Be forewarned that the document is not yet adopted by the NBRG, which can only be
This post is a status update on the NBRG RMWG Risk Management Consensus Document 30 April 2014 – The NBRG (Notified Body Recommendation Group) Risk Management Working Group (RMWG) membership will have a face to face meeting in mid May to
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