Are You Prepared for EN ISO 14971

Noblitt & Rueland

The updated “EN ISO 14971:2012 Medical Devices – Application of risk management to medical devices” standard was published August 30, 2012 in the Official Journal as harmonized to the Medical Device Directive, Active Implantable Medical Device Directive, and In Vitro Diagnostic Medical Device Directive and became effective immediately without a transition period. Transition periods typically have been identified for updates to other standards.