Eisner Safety Consultants provides affordable, on-time product approvals via safety & regulatory agencies to medical device companies. We provide assistance with U.S., Canadian, European, & other international regulations. A summary of our services include: * Provide Gap Analysis to IEC 60601-1 * Provide IEC 60601-1 product safety & Risk Management File support * Internal & Supplier Audits to ISO 13485, QSR, MDD, CMDR, & ISO 9000, * Preparing 510(k)s, assist with PMA & IDE submissions * Assist in preparation & assessment of Technical Files & Design Dossiers for European Directives/Regulations (MDD, AIMDD, MDR) & Canadian Medical Device Requirements & DHF's (US) * Preparation of Clinical Literature Evaluations. Evaluation of Clinical Data per MEDDEV 2.7.1 requirements of the MDD/AIMDD/MDR * Set-up Quality Systems, FDA, MDD/MDR & CMDR procedures * Assist with Software Verification & Validation Protocols & Reports * Assist with Usability Engineering Process to IEC 62366 & IEC 60601-1-6 * Assist with Risk Analysis/Management & Software Risk Analysis per ISO 14971 * Provide Product Safety Design Support, including Gap Analysis/Construction Evaluation, Review/generation of product Labeling & Markings, assistance in the selection & review of safety critical components * Act as a Compliance Engineer for any of your product safety needs, including Interface with Test Agencies (UL, CSA, etc.) * Provide IEC 60601-1-2, EMC support