Whitepapers - Audits/inspections

  • Design Control: Practical Points to Consider

    Noblitt & Rueland

    1/30/2014

    FDA continues to cite manufacturers with serious Design Control violations found during inspections which lead to Warning Letters. Very recently a company received a Warning Letter that includes significant design...

  • Are You Prepared for EN ISO 14971

    Noblitt & Rueland

    1/30/2014

    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...