Our Profile

Eisner Safety Consultants experts provide affordable, on-time medical device approvals via safety and regulatory agencies (including technical documentation), and quality system certifiers. Our experts can help prepare design documentation.  We provide assistance with U.S., Canadian, European, and other international markets.

Services we offer:
    • Safety/EMC Support (60601 Series & Other Medical Device Standards)
      • Gap Analysis to Safety/EMC Standards
      • Construction Review to Safety/EMC Standards
      • Prepare / Review Essential Performance Analysis
      • Prepare Test Plan for Safety/EMC Standards
      • Prepare/Review Test Agency Submission paperwork (i.e. Risk Management File for 60601, Usability Engineering File per IEC 60601-1-6 & 62366 or 62366-1, Software Lifecycle Process per 62304, etc.)
      • EMC Failure Remediation
      • Generation of product Labeling and Markings
      • Selection/Review of safety critical components
      • Act as a Compliance Engineer for your Company
      • Support Test Agency Submissions including interface with Test Agency
    • Technical Documentation Support (EU, US, Canada)
      • Gap Analysis to EU MDR requirements
      • Prepare/Assess EU MDR Technical Documentation or EU MDD Technical File or Design Dossier
      • Prepare/Assess US Design History File (DHF)
      • Prepare/Assess Canadian Technical Documentation required by Canadian Medical Device Regulations (CMDR)
      • Prepare/Assess  EU MDR General Safety and Performance Requirements
      • Prepare/Assess Canadian Safety and Effectiveness Requirements per CMDR
      • Prepare Clinical Literature Evaluation Reports per MEDDEV 2.7.1 Rev 4 (MDD/MDR)
    • Regulatory Submissions & Additional Support
      • Prepare & support Pre-Sub meetings
      • Prepare/Assess 510(k) submissions
      • Assist with PMA & IDE submissions
      • Support response for FDA requests during or after review of submissions
      • Risk Analysis per ISO 14971 and EN 14971
      • Software Verification and Validation Protocols/Reports (IEC 62304)
      • Usability Engineering Process per IEC 62366/62366-1 & IEC 60601-1-6
      • Review of product literature/packaging/labeling to MDD, AIMDD, MDR, CMDR, FDA, UDI, & IEC 60601 series requirements
    • Quality Systems Support
      • Set-up Quality Systems, FDA, EU MDR / MDD, and CMDR procedures for your company
      • Audit your company to ISO 9000, ISO 13485, FDA QSR’s, MDR / MDD (EU CE Mark) and MDSAP / CMDR
      • Set-up and maintain your company’s standards and regulations list
    • Preparation of design documentation
      • User Needs Specification
      • Use Error FMEA
      • Risk/Hazard Analysis
      • Essential Performance Analysis for IEC 60601 standards
      • Risk Management File
      • Product Requirements Specification
      • Requirements Traceability
      • Design Controls
      • Applicable Standards Analysis
      • IFU/Operator Manual Requirements
      • Labeling Requirements
      • Label Design
      • Design Review
    • Assist in US &/or International Standards Development for your Company

    We have access to medical device regulatory experts in other areas including Sterilization and Biocompatibility.

    For further information on any of our services please contact us.

    About Our Clients

    Our experts work with companies large and small, with as few as two employees, and with multiple divisions and staffs in the thousands. Most of our clients are smaller in size, need high quality regulatory services, but found it impossible to afford a salaried compliance or regulatory professional.

    Nevertheless, large, multidivisional corporations have used one or more experts for specific projects or tasks. Even in a large company, it may make business sense to rely on the expertise of ESC associates to supplement fully loaded resources in “worker-bee”, leader, or manager mode.