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
View Top Employees from Eisner Safety ConsultantsWebsite | http://www.eisnersafety.com |
Revenue | $195000 |
Employees | 4 (4 on RocketReach) |
Founded | 1997 |
Phone | (503) 244-6151 |
Technologies |
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Industry | Medical Equipment Manufacturing, Business Services General, IEC 60601-1 2nd & 3rd ed., Business Services, 510(k), IEC 60601 Series of Standards, ISO 13485, ISO 14971, FDA, QSRs, MDD, AIMDD, CMDR, DHFs (FDA), Technical Files (EU), EU Design Dossiers |
Web Rank | 14 Million |
Keywords | Typical Value For Leakage Current, Eisner Safety Consultants, Can/Csa C22.2 No 60601-1-14 Changes |
Competitors | Dynamix Solutions, HealthFocus International, Investment & Research, MLOVE Foundation, RiskWorld |
SIC | SIC Code 87 Companies, SIC Code 874 Companies |
NAICS | NAICS Code 541 Companies, NAICS Code 54 Companies, NAICS Code 5416 Companies |
Looking for a particular Eisner Safety Consultants employee's phone or email?
The Eisner Safety Consultants annual revenue was $195000 in 2024.
Cornelius Amelunxen is the Owner and Operator of Eisner Safety Consultants.
4 people are employed at Eisner Safety Consultants.
Eisner Safety Consultants is based in Portland, Oregon.
The NAICS codes for Eisner Safety Consultants are [541, 54, 5416].
The SIC codes for Eisner Safety Consultants are [87, 874].