World Wide Web Links
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
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
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.
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
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
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.
European Union New Approach
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
Regulations - Title 21 Code of Federal Regulations (CFR)
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.
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.
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
<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.
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
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
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
IEC Site map
- This is the official IEC (International Electrotecnical
Commission) site. IEC is a standards writing organization for Electrical
based International 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
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
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.
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/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
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.
Online - Site with product center, career center, news and other information
for medical device designers.
Regulatory Profiles for Select Foreign Markets - Through a partnership of
the U.S. Department of Commerce and the National Electrical Manufacturer's
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.
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.
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.
- 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
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 - 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.
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
Theraputic Goods Administration
- Australian medical device requirements.
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
Underwriters Laboratories Logo Artwork
Contacts for the EU