Eisner Safety Consultants (ESC) provides affordable, on-time product approvals via safety and regulatory agencies. The company provides support to medical device companies. We provide assistance with U.S., Canadian, European, and other international regulations. We can:
* Act as a Compliance Engineer on an as-needed basis for any of your product safety needs (i.e. IEC 60601 series)
* Provide Gap Analysis on your product(s) to IEC 60601-1, 3rd Edition (Edition 3.0 or 3.1)
* Provide IEC 60601-1, 2nd OR 3rd Edition (Edition 3.0 or 3.1) product safety support
* Provide IEC 60601-1, 3rd Edition (Edition 3.0 or 3.1) Risk Management File support
* Provide IEC 60601-1-2, EMC support including Test Plan Preparation, Essential Performance Analysis, Risk Management and full Marking and Labeling support
* Support Test Agency Submissions, including Interface with the Test Agencies (UL, CSA, TUV, NEMKO, Intertek, etc.)
* 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
* Assist in the development of International Safety Standards
* Set-up and maintain your company’s standards and regulations list
– Check out our Annual Standards Report to keep up on all new & draft Standards & Technical Reports for Medical Electrical Equipment & Systems (MEE&S) & for Home Use MEE&S. This includes regulatory updates for applicable documents.
* Prepare 510(k)s.
* Assist with PMA & IME submissions
* Assist with preparation and assessment of technical files and design dossiers for European Directives (MDD & AIMDD), EU Regulation (MDR), Canadian Medical Device Requirements (CMDR) and DHFs (US)
* Assist in preparation of EU and/or CMDR Essential Requirement checklists & Risk Analysis per ISO or EN 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, & IEC 60601 series (including general, collateral, & particular standards in series) requirements
* Set-up Quality Systems, FDA, MDD, (& MDR) and CMDR procedures for your company
* Audit your company to ISO9000:2000/2015, ISO 13485:2003/2016, QSR, MDD (EU CE Mark) and CMDR or the soon to be required MDSAP
* Assist with your Software Verification and Validation Protocols and Reports (IEC 62304)
* Assist with your Usability Engineering Process per IEC 62366 & IEC 60601-1-6
* Assist with your Risk Analysis, Risk Management, & Software Risk Analysis per ISO 14971

We have access to medical device regulatory experts in many other areas including Sterilization, Biocompatibility, Software Risk Analysis, etc.