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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

AdvaMed (Previously HIMA - Health Industry Manufacturers Association) The Advanced Medical Technology Association (AdvaMed) is a medical technology trade association, supported by more than 800 medical device, diagnostic products and health information systems manufacturers of all sizes. AdvaMed operates globally to promote a legal, regulatory and economic climate that advances health care by assuring worldwide patient access to the benefits of medical technology.
The Association for the Advancement of Medical Instrumentation (AAMI)
, founded in 1967, is a unique alliance of nearly 7,000 members united by the common goal of increasing the understanding and beneficial use of medical instrumentation.   AAMI is the primary source of consensus and timely information on medical instrumentation and technology, and is the primary resource for the industry, professions, and government for national and international standards.
American National Standards Association (ANSI)    
American Society for Testing and Materials (ASTM)

American Society for Quality (ASQ) is a society of individual and organizational members dedicated to the ongoing, development, advancement, and promotion of quality concepts, principles, and techniques.
ASQ has products, services, and–most of all–information to help people in all walks of life grapple with perplexing issues like total quality management, benchmarking, productivity, and more.
Biomedical Translations -  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.
British Standards Institute (BSI) - can provide standards and quality management services.  They also provide product testing, global trade inspection, environmental management, information security, among other services. 
BSI Medical Directive Site
- Guidance Documents for the Medical Device Directive and more.
CB Scheme
- The fundamental principles of the CB scheme is that a manufacturer can obtain a CB Test Certificate for a product, which means that a National Certification Body (NCB) has tested the product and found it to be in conformity with a specified standard. The manufacturer can then present this certificate to the NCBs in other countries whose certification marks the manufacturer wants for their products.  For a list of countries and the applicable standards the labs are accredited to go to the CB Scheme website.
CDRH Laser Product Requirements and Guidances - Website that provides regulatory information for CDRH Laser requirements.  You can obtain CDRH guidance documents and many other valuable resources.
Compliance Engineering
- The magazine for International Regulatory Compliance covers topics including EMC, ESD, Product Safety, Medical Products, Telecommunications and ISO Standards, etc.
Conversion Tables - A useful site that has many conversions for temperature, mass, pressure or stress, force, volume,area, length, etc.
ED&D
- ED&D is a leading company making test equipment for product safety applications. They offer a full line of test equipment, from Hipot testers to Accessibility Probes, to Humidity Chambers to Force Gauges - - whatever the requirements of your particular Standard call for, they can provide the highest quality equipment available.   Note: when ordering use code EDDE
EMI Solutions - A detailed database of manufacturers of EMI electrical components, mechanical components, test equipment, EMC software; and test labs, calibration service, gasket and shielding materials, filter and ferrites, and antennas.  This site is provided by Canon Communications.
European Commission home page European Union New Approach Directives European Commission home page
This is a very useful website that lists the EU New Approach Directives including; the text of the directive, list of Harmonized standards under the specific directive, and a list of current standards activities for the specific Directives.
FDA Regulations  - Title 21 Code of Federal Regulations (CFR)

FDA Consensus Standards
- A very useful site which is a CDRH database of applicable standards.   Search by standards organization,  category, product code, reference number or title.
FDA Guidance Document Addressing Human Factors Engineering Design
- A new FDA guidance document, "Medical Device Use -- Safety:  Incorporating Human Factors Engineering into Risk Management," describes the role of human factors techniques and risk-assessment theory in device design.  The guidance is intended to assist manufacturers and reviewers of premarket device submissions and design control documentation.  
FDA Warning Letters - FDA database warning letters search limited to search by company name, issue date, issuing office and subject.  Necessary to register as a member before using.

Global Engineering Documents
- Source for Standards National & International.  Also, you can contact almost any Standards writing body through SafetyLink.com and find sources to get these documents through the Standards writing body.
  HomeThe Global Harmonization Task Force (GHTF) was conceived in 1992 in an effort to respond to the growing need for international harmonization in the regulation of medical devices. The Chairmanship of the GHTF is rotated amongst the regulatory representatives of the five founding members; Canada, United States, European Union, Japan, and Australia.
HPK Group  LLC - Process Improvement Consulting
<HAR> - This is a European mark for cordage (power cords) that is accepted throughout the countries in the <HAR> (Harmonized cordage) program.  Also see our page for explanation of HAR system and other details.
IEC 417 symbols - This database is no longer available. 
ICPD Seminars are designed to develop and expand skills of Mechanical Designers and Engineers working in or entering the filed of new product design and invention.  Seminars teach design of plastic injection molded parts, sheet metal, metal extrusion, and metal casting design.
IEC 60601: publication(s) - This link list the currently published IEC 60601-X  (Electro-medical) based standards and also details the IEC 60601-X based standards that are in process.
IEC 60335: publication(s) - This link list the currently published IEC 60335-X (household and similar electrical appliances) based standards and also details the IEC 60335-X based standards that are in process.
IEC Site map
- This is the official IEC (International Electrotecnical Commission) site.  IEC is a standards writing organization for Electrical based International Standards.
IEC Standards Writing Info Site (Weblink no longer availble)-This site is maintained by Chiba University in Japan and has some useful information if you want to understand the IEC standard writing process.
Institute of Electrical & Electronics Engineering, Inc. (IEEE) - The IEEE promotes the engineering process of creating, developing, integrating, sharing, and applying knowledge about electro- and information technologies and sciences for the benefit of humanity and the profession.
IEEE Grid - San Francisco Bay Area calendar of events for IEEE technical meetings, seminars, conferences and workshops.
Image Associates -  They  specialize in supplying high quality custom fabricated products, such as Printed Circuit Boards, P.C. Board Assembly, Metal Fabrication, Plastics and Cable/Harness Assembly.  Also, they offer aggressively priced off-the-shelf and custom components such as AC Power Cords and DC-DC Power Converters. In addition, services such as Technical Writing, Safety Agency Consultation and PCB Design are offered by Image Associates.
International Product Safety Newsletter - 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. 
i-spec - the Product Designer's on-line guide to compliance with IEC 60950, the International Safety Standard for Information Technology Equipment.
ISO
- This is the official ISO (International Standards Organization) site.  ISO is a standards writing organization for typically non-Electrical based International Standards.  This site can point you towards quality system standards ISO 9000:2000 and ISO 14000. 
ISO Standards Catalogue
ISO/TC176/SC 2 - ISO's Technical Committee no.176, Sub-committee no.2 (ISO/TC 176/SC 2) is responsible for the development of the ISO 9001 and ISO 9004 International Standards as well as other International Standards and documents in the ISO 9000 Family.
This site  is hosted by the British Standards Institution, which provides the Secretariat to ISO/TC 176/SC 2. 
Lean Workshops.com
  Customized Lean Workshops
MEDDEV's - Medical Device Directive Guidance Documents issued from the official EU website for EC Directive.
Medibix.com
- Online Component Database source of global product information for high-tech components. Component Database has an electronic catalogue of over 357,352 products, 2.5 million specifications, and 21,679 companies with comprehensive listings not only for the US, but also for the UK, Germany, and Japan. Their electronic catalogues allow an engineer to search thousands of products by individual specifications in order to locate a specific hard-to-find component. In addition, they have an extensive consulting and service directory which includes: FDA consulting, CNC machining, plastic molding, PCB design, testing laboratories, etc. If you're looking for a motor, valve, pump, filter, tube, power supply, or sensor, save time by first searching Component Database.
Medical Device & Diagnostic Industry - The magazine of medical product design, manufacturing and marketing.
Medical Device Link - This site provides news and information for people who design, manufacture, and market medical devices. The site is produced and maintained by Canon Communications, a company known throughout the medical device industry for its  print publications and international trade shows. Medical Device Link compiles articles from all of Canon's print magazines and offers a number of features exclusive to the site, including daily news and analysis, subject-based bulletin boards, and links to useful industry resources. The site also has several searchable directories listing thousands of companies in the U.S. and overseas who supply components, equipment, materials, and services to manufacturers of medical products. In the Career Center, you'll find the latest industry job postings as well as a resumé board.
Medical Device Online - Site with product center, career center, news and other information for medical device designers.
Medical Device Regulatory Profiles for Select Foreign Markets - Through a partnership of the U.S. Department of Commerce and the National Electrical Manufacturer's Association (NEMA).
M.E. SOLUTIONS is a San Diego based mechanical engineering design firm with 25 years experience offering product designs in the medical, consumer, and military product categories. Design expertise includes electro-mechanical devices, electronic product packaging, and design for harsh environments. Product designs may include plastic injection molded parts, sheet metal, metal extrusion, and metal casting parts. Designs are prototyped and assisted into production.
Nationally Recognized Test Laboratories (NRTL)   - The NRTL Program is a part of OSHA’s Directorate of Technical Support. The Program recognizes private sector organizations as NRTLs, which designates that the organization has met the necessary qualifications specified in the regulations for the Program. The NRTL determines that specific equipment and materials ("products") meet consensus-based standards of safety to provide the assurance, required by OSHA, that these products are safe for use in the U.S. workplace.
Notified Body Lists - Official list of Notified Bodies per EU Directive.
Notified Body Decisions for the MDD, AIMDD, IVDD.  Provided by Donawa & Associates website
Obelis, S.A. - 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 2nd 2001, O.E.A.R.C. is 9001:2000 certified by Lloyd’s Register Quality.
QuadTech - ISO 9001 Certified manufacturer, offering a complete line of Hipot testers and safety analyzers, automatic transformer test systems, megohmmeters, milliohmmeters, and LCR meters for testing passive components, as well as calibration and repair services.
SafetyLink.com
- Readily access the World's electrical product safety approval test labs including CSA Int'l, FM, the NRTls, SEMKO, the TUVs, UL, VDE and 100's more; standards bodies such as ANSI, CENELEC, IEC, EIA, and ETSI; government links such as CPSC, FCC, OSHA, NIST and the EUs, etc.  This site is provided by Product Safety International.
Signal Transformers - A technical library resource for application notes for power supplies for various applications, including medical.
601help - A tool for the Medical Device Developer's to IEC 60601-1, the International Product Safety Standard for Medical Equipment.
Six Sigma Workshops -   Customized Six Sigma Workshop. 
The SMi Group 
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A market research based organization.  SMi take pride in the quality of our programs and publications, ensuring that they are brought to the attention of the key decision makers in each industry sector that we operate in. Sectors we our currently involved in include Pharmaceuticals, Telecom, Commercial Aviation, Finance, Energy, IT and Internet and more.   We cultivate and maintain strong industry contacts to ensure that we are informed of all pending changes in government and regulatory policy, and we regard our relationships with speakers, delegates and subscribers as an investment for the future.
Technologies West represents a variety of electronic test equipment manufacturers in California, Nevada, Maquiladoras (Mexico) and Hawaii for: Product Safety, EMC, Power supplies, Racks and Cabinets, cPCI, PXI, VXI and Embedded Systems.
Theraputic Goods Administration
- Australian medical device requirements.
Transposition Documents for the MDD/IVD/AIMMD
Underwriters Laboratories - A link to UL Recognized components directory, a good resource to
locate components that require certification.   UL is an independent, not-for-profit product safety testing and certification organization.  UL has tested products for public safety for over a century.  UL is not affiliated with Eisner Safety Consultants and does not endorse this web site. 
Underwriters Laboratories Logo Artwork
Vigilance Contacts for the EU


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Last modified: April 08, 2009