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ESC Affiliates

ESC works with other consulting groups and companies to provide additional services

Disclaimer: Links to organizations found at this site are provided solely as a service to our visitors. These links do not constitute an endorsement of these organizations or their programs by Eisner Safety Consultants,  and none should be inferred. Eisner Safety Consultants is not responsible for the content of the Web pages found through these links

GreenSoft
Technology, Inc.

GreenSoft Technology is a leading provider of environmental compliance data services and software for the global electronics industry, including medical device manufacturers. GreenSoft helps companies comply with global chemical and substance regulations and directives like RoHS and REACH.

 

 

The Newsletter Devoted to Product Safety Compliance  “INTERNATIONAL PRODUCT SAFETY NEWS” (IPSN), founded in 1988, is the newsletter for those involved in International Product Safety Compliance.  Subscribers include the safety agencies, product safety consultants and product safety professionals around the world.  IPSN is a six-times-a-year updating service, which features news, information, interviews and resources concerning Safety Agency approvals such as UL, CSA, the NRTLs, VDE, IEC, and TUV.

ForeignExchange Translations

(Click link for Contact Info)

ForeignExchange Translations is raising the bar when it comes to providing linguistic services to the life sciences. Our processes are ISO 9001:2000 certified, and provide a new standard for delivering multilingual products and documents on time and on budget. We’ve blended expert linguists, best-of-breed technology and measurable quality into a process that is both robust and completely scalable. In addition, our FXTracker online interface enables clients to track their projects every step of the way, meaning greater control and peace of mind. ForeignExchange works in all major languages, with operations centers in the US, Canada and Europe. For more information, please visit our website at www.fxtrans.com.

CRO Group

PO Box 1098  –  32 Harrison Street
Melrose, MA 02176 USA
Contact:  info at crogroup dot com
781.665.9893
781.665.5547 (Facsimile)

A global consulting organization for medical, biotechnology, and in vitro diagnostic device companies needing CE Marking, design and development, clinical investigation, quality assurance and regulatory affairs, environmental management, export and reimbursement, and due diligence assessments services.

DeviceLab Inc.
2691 Richter Ave.,
Unit #128
Irvine, CA 92606
info at devicelab dot com
714.542.9400
714.542.9494 (Facsimile)

Device Lab is a full-service product engineering and development firm that specializes in medical devices and electro-mechanical enclosures.  They offer rapid product development services that range from concept generation to turnkey operations, including generation of one-of-a-kind or multiple functional prototypes, and vendor sourcing.   Capabilities include industrial design, graphic design, mechanical and electrical engineering, software and prototyping.

European
Authorized Representative Center
Obelis S.A.
Avenue de Tervueren, 34 bte 44
1040 Brussels B-1040 BELGIUM
mail at obelis dot net
+32.2.732.59.54
+32.2.732.60.03 (Facsimile)

Obelis European Authorized Representative Center (O.E.A.R.C.) is a European-based consulting company providing European Authorized Representative
and CE Marking services to non-European medical devices manufacturers under AIMD, MDD, and IVD European Directives. Our fully integrated solutions include certification of “Class I” medical devices and IVD medical devices, technical file management and incident reports to European competent authorities, initial marketing setup, and clinical-trial services. Since May 2001, O.E.A.R.C. is ISO 9001:2000 certified by Lloyd’s Register Quality.

Net-Translators
Ltd. Europe

Avenue de Tervuren 34, P.O.B 44
1040, Brussels, Belgium
sales at net-translators dot com
+ 32.2.732.59.54
+ 32.2.732.60.03

In the medical world quality translations are not a matter of luxury; they are critical! Net-Translators provides translation services to hospitals, medical equipment manufacturers, pharmaceutical firms, clinicians, and researchers. Because localization demands total accuracy and zero tolerance for misinterpretation, we employ over 300 translators across the globe, each located in a country where their native language is spoken. Net Translators also specializes in software translation for the medical device industry

Image Associates
3617 E. Thousand Oaks Blvd.,
Suite 123
Westlake Village, CA 91362
sales at imageassoc dot com
805.777.1106
805.777.1136 (Facsimile)
805.279.0466 (Cell)

Manufacturer’s representative of custom fabrication and specialized components including PCB’s/PWB’s – flex & rigid, precision metal fabrication, plastic fabrication, cable & harness assemblies, power supplies (including medical), power cords (including hospital grade), etc.

Biomedical Translations
PO Box 5376
Modesto, CA 95352-5376 USA
info at biomedical dot com
209.578.3539
209.758.0952 (Facsimile)

They provide foreign language translation to the medical device, medical diagnostic, and other high tech equipment companies. They offer the full range of translation needs, from proofreading and editing by medical specialists to formatting and typesetting, including any non-roman character language, such as Japanese, simplified and traditional Chinese, etc.

Their editors have Medical degrees from their country of origin and their translators have a MS in translation and years of experience working for the medical industry.

Send them  your document for a free estimate

Safety Consultants

If for whatever reason we’re not a good fit with your needs, we can recommend all of the following consultants.  All are expert, responsive medical device compliance specialists.  We’ve included the name of the principal, and the office location.

Medical Equipment Compliance Associates, LLC,
Brian Biersach, Milwaukee, WI

O’Brien Compliance Management,
Frank O’Brien, Lowell, MA

Strategic Device Compliance Services,
Mike Schmidt, Cincinnati, OH