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List of Client Services

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:

Ø Prepare 510(k)s.

Ø Assist with PMA & IME submissions.

Ø 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).

Ø Set-up Quality Systems, FDA, MDD, and CMDR procedures for your company.

Ø Assist in preparation of EU and/or CMDR Essential Requirement checklists, and Risk Analysis per ISO 14971.

Ø Audit your company to ISO 9000:2000, ISO 13485:2003, QSR, MDD (EU CE Mark) and CMDR.

Ø Act as a Compliance Engineer on an as-needed basis for any of your product safety needs.

Ø 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.

Ø Provide IEC 6060101, 2^nd OR 3^rd Edition product safety support.

Ø Provide IEC 60601-1-2, 2^nd Edition EMC support including Test Plan Preparation, Essential Performance Analysis, and full Marking and Labeling support.

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

Ø Assist in the development of International Safety Standards.

We have access to medical device regulatory experts in many other areas including Sterilization, Biocompatibility, EMC,  Software Risk Analysis, Software Validation, FDA, and Clinical Study support.  

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