Eisner Safety Consultants

Eisner Safety Consultants provides affordable, on-time product approvals via safety & regulatory agencies to medical device companies. We provide assistance with U.S., Canadian, European, & other international regulations.

A summary of our services include:
* Provide Gap Analysis to IEC 60601-1
* Provide IEC 60601-1 product safety & Risk Management File support
* Internal & Supplier Audits to ISO 13485, QSR, MDD, CMDR, & ISO 9000,
* Preparing 510(k)s, assist with PMA & IDE submissions
* Assist in preparation & assessment of Technical Files & Design Dossiers for European Directives/Regulations (MDD, AIMDD, MDR) & Canadian Medical Device Requirements & DHF’s (US)
* Preparation of Clinical Literature Evaluations. Evaluation of Clinical Data per MEDDEV 2.7.1 requirements of the MDD/AIMDD/MDR
* Set-up Quality Systems, FDA, MDD/MDR & CMDR procedures
* Assist with Software Verification & Validation Protocols & Reports
* Assist with Usability Engineering Process to IEC 62366 & IEC 60601-1-6
* Assist with Risk Analysis/Management & Software Risk Analysis per ISO 14971
* Provide Product Safety Design Support, including Gap Analysis/Construction Evaluation, Review/generation of product Labeling & Markings, assistance in the selection & review of safety critical components
* Act as a Compliance Engineer for any of your product safety needs, including Interface with Test Agencies (UL, CSA, etc.)
* Provide IEC 60601-1-2, EMC support

Company’s Keywords:

iec 606011 2nd, 3rd ed, 510, iec 60601 series of standards, iso 13485, iso 14971, fda, qsrs, mdd, aimdd, cmdr, dhfs, technical files, eu design dossiers