Leo Eisner

Bio

We provide affordable, on-time product approvals via safety & regulatory agencies. We support medical device, IVD, & high tech companies. We provide assistance with U.S., Canadian, European, and other international regulations. We can: • Prepare 510(k)s, assist with PMA & IDE submissions • Assist with preparation & assessment of Technical Files & Design Dossiers for European Directives (MDD, AIMDD, LVD, EMC, IVD) and Canadian Medical Device Requirements (CMDR) and DHF’s (US) • Assist in preparation of EU and/or CMDR Essential Requirement checklists • Assist in the preparation of Clinical Literature Evaluations. Evaluation of Clinical Data per MEDDEV 2.7.1 to meet the requirements of the MDD/AIMDD • Review of product literature/packaging/labeling to MDD, AIMDD, CMDR, FDA, and IEC 60601 series (including general, collateral, and particular standards within the series) requirements • Set-up & maintain your company’s standards and regulations list • Set-up Quality Systems, FDA, MDD, and CMDR procedures for your company • Audit your company to ISO 9000:2000, ISO 13485:2003, QSR, MDD (EU CE Mark) & CMDR • Assist with your Software Verification & Validation Protocols and Reports • Assist with your Usability Engineering Process per IEC 62366 & IEC 60601-1-6 • Assist with your Risk Analysis, Risk Management, and Software Risk Analysis per ISO 14971 • Act as a Compliance Engineer on an as-needed basis for any of your product safety needs • Provide Product Safety Design Support, including Gap Analysis/Construction Evaluation, Review and generation of product Labeling and Markings, assistance in the selection and review of safety critical components • Provide IEC 60601-1, 2nd OR 3rd Edition product safety support (incl. Gap Analysis) & 3rd Edition Risk Management File support • Provide IEC 60601-1-2, EMC support • Support Test Agency Submissions, including Interface with the Test Agencies (UL, CSA, TUV, Intertek, etc.)