Eisner Safety Consultants

Eisner Safety Consultants (ESC) provides affordable, on-time product approvals via safety and regulatory agencies. The company provides support to medical device, IVD, and 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 and assessment of Technical Files and 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, and Risk Analysis per ISO 14971

• 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 and 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) and CMDR

• Assist with your Software Verification and 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 Gap Analysis on your product(s) to IEC 60601-1, 3rd Edition

• Provide IEC 60601-1, 2nd OR 3rd Edition product safety support

• Provide IEC 60601-1, 3rd Edition Risk Management File support

• Provide IEC 60601-1-2, EMC support including Test Plan Preparation, Essential Performance Analysis, and full Marking and Labeling support

• Support Test Agency Submissions, including Interface with the Test Agencies (UL, CSA, TUV, NEMKO, Intertek, etc.)

• Assist in the development of International Safety Standards

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

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

About Our Clients

ESC works 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 regulatory professional.

Nevertheless, large, multidivision corporations have used one or more ESC associates for specific projects or tasks. Even in the 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.

A sampling of our clients are listed as references & services we provided to them.