John Zorich
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Affiliated Agencies and Companies
The following people, agencies, and companies have
in the past, at our request and recommendation,
provided to our clients services that we do not:
Affiliates
Private
seminars
Client List
Michael A. Daniel
-- Daniel & Daniel Consulting
--
Clinical and Regulatory Medical Device consulting, including strategy,
and 510(k), PMA, and IDE preparation
--
madaniel@clinregconsult.com
-- http://www.clinregconsult.com

Hendron & Associates   Human Resource consultancy services to start-
ups in life sciences &  hi-tech, in the areas of:
-- Legal Compliance
-- Benefits & Stock Plans
-- Recruitment & Training
-- Employee Relations
--
mhendron@pacbell.net

MDSS
-- Medical Device Safety Service
-- MDSS acts as your
Authorized Representative in the European Union
(MDD, AIMDD, IVDD)
--
info@mdss.com
-- http://www.mdss.com

MMC  ("Manufact Pro -- Software for Manufacturing")
-- Documents, Materials, Parts and Quality Assurance software database
product focused on manufacturing of products and compliance with
GMPs and ISO standards. Our specialty is the Medical Device Industry.
-- MMC is the consulting firm that created and supports the Manufact Pro
product and numerous custom data solutions. We specialize in
quickly building solutions for companies regulated by the FDA and for
ISO compliant companies. We are a FileMaker Solutions Alliance
Member.
--
info@mmcpro.com
-- http://www.mmcpro.com

Dufour Law Group
-- James T. Dufour, J.D., C.I.H., R.E.A.
--
Environmental and OSHA regulatory compliance services
-- Environmental and OSHA compliance training & update seminars
-- Clients and seminars throughout California
-- Main office at 831 F Street, Sacramento, California 95814
-- Telephone:  916-553-3111
--
jtdufour@aol.com

Business Performance Associates, Inc.
-- Tim Stein, President/CEO
-- Quality systems, ISO 9001, 13485, QSRs, cGMPS
--
Software development processes for medical devices (IEC 62304)
-- Risk management
-- Software validation – software applications for production and quality systems
--
www.BPAconsultants.com
-- 408-366-0848 office
-- 408-768-7538 cell

Leo Eisner  ---  Eisner Safety Consultants
-- IEC/EN 60601-1, 2nd & 3rd editions including Risk Mng File requirements of 3rd ed.
--
IEC 60601 series of standards
-- EU MDD, AIMDD, IVDD Technical Files/Design Dossiers
-- 510(k)s, PMAs, IDEs
-- Quality systems, ISO 9001, 13485, MDD, CMDR, QSRs
-- Internal & Supplier Audits
-- Risk Management to ISO 14971
-- Usability Engineering Process per IEC 62366 & IEC 60601-1-6
-- Update/Maintain your Company's Standards & Regulations Library
-- Development of International Standards
-- Software development processes (IEC 62304) & Software validation
--
www.EisnerSafety.com
-- 503-244-6151 (Office)
-- 503-709-8328 (Cell)
--
Leo@EIsnerSafety.com

The Halper Group ---  Laura A. Halper, Ph.D.
-- Training programs tailored to your needs
-- Internal and supplier audits
--
Regulatory and quality system consulting
-- FDA, Canada, Europe, other international
--
www.TheHalperGroup.com
-- 972-612-0214
--
thg@sprintmail.com
Public
seminars