Industry Organizations of Interest
to Medical Device Manufacturers
The Adhesive and Sealant
Council Inc. (ASC) is a nonprofit trade association incorporated in 1958
for the purpose of providing opportunities for dialogue, education, advancement,
and improvement of all aspects of the adhesive and sealant industry. It offers
semiannual conventions, technical short courses, government relations, statistics,
and publications, and it promotes industry awareness in a variety of forums.
AdvaMed,
the Advanced Medical Technology Association (formerly the Health Industry Manufacturers
Association), represents more than 800 innovators and manufacturers of medical
devices, diagnostic products, and medical information systems. AdvaMeds
members produce nearly 90% of the $68 billion worth of healthcare technology
products consumed annually in the United States, and nearly 50% of the $159
billion worth purchased around the world annually.
The American Association for
Clinical Chemistry (AACC) is an international scientific society of more
than 10,000 individuals that work in clinical laboratories or in the IVD industry.
Members specialize in fields such as clinical chemistry, biochemistry, immunology,
molecular pathology, medical technology, clinical pathology, toxicology, and
laboratory management. AACC publishes three periodicals, the Clinical Chemistry
Journal, Clinical Laboratory News, and Strategies. AACC Press is a major publisher
and distributor of books in clinical laboratory science and practice. Educational
meetings are held throughout the year culminating in its annual meeting and
Clinical Lab Expo in late July. AACC offers an on-line job service and is also
involved in government and regulatory affairs.
The American Association
for Homecare (AAHomecare) is the only all-inclusive national assocation
representing the full spectrum of the home-care industry, including IV therapy,
home medical equipment manufacturers and suppliers, and home-health providers.
AAHomecare was formed by the merger of the Health Industry Distributors Associations
Homecare Division, the Home Health Services & Staffing Association, and
the National Association for Medical Equipment Services. Combining the expertise
and strengths of each organization, AAHomecare is an effective advocate for
sound public policy with respect to home care.
The American
Institute for Medical and Biological Engineering (AIMBE) was formed in 1991
with the sponsorship of the National Science Foundation to assist various constituencies
of the medical and biological engineering community on issues of mutual interest.
The institute offers a forum for catalyzing broad involvement of engineers,
representation of medical and biological engineering on issues of national interest,
and research on policy issues related to the development and evaluation of the
appropriate use of technology in medicine and biology. The organization also
offers workshops and courses designed to educate the professional community
and the public at large. Fifteen scientific societies representing the full
spectrum of bioengineering research and education in the United States are full
members of AIMBE.
The American National Standards
Institute (ANSI) is a federation of organizations that establishes a national
consensus on domestic and international standards and conformity assessment
policy as it relates to trade, regulatory matters, and the integrity of the
U.S. standards development system. The institutes membership includes
nearly 1400 organizations from the business community; professional and engineering
societies; trade associations; federal, state, and local government agencies;
consumer interests; labor; academia; laboratory and testing organizations; and
other entities. The institute approves American National Standards and ensures
that its guiding principlesconsensus, due process, and opennessare
followed by accrediting and auditing nearly 175 standards organizations. ANSI
represents the United States at the International Organization for Standardization
(ISO), the International Electrotechnical Commission (IEC) via the institutes
U.S. National Committee to the IEC, the International Accreditation Forum (IAF),
and several regional standards and conformity assessment organizations.
The American Society for Clinical
Laboratory Science (ASCLS) is a large nonregistry professional association
for nonphysician clinical laboratory professionals. Its 12,000 members include
hematologists, phlebotomists, immunologists, immunohematologists, clinical chemists,
microbiologists, managers, and educators.
Founded in 1946, the American
Society for Quality (ASQ) is a quality source for information on the development,
promotion, and application of quality strategies and techniques. The professional,
not-for-profit association serves more than 130,000 individuals and 1000 sustaining
members.
A primary source of voluntary standards for materials, products, systems, and
services, the 33,000 members of the American
Society for Testing and Materials (ASTM) contribute their time and expertise
to the development and maintenance of standards and related technical information.
More than 11,000 standards are published in the 75-volume Annual Book of ASTM
Standards.
Association for the Advancement
of Medical Instrumentation (AAMI) Founded in 1967, AAMI represents nearly
7000 professionals focused on medical instrumentation. This Web site contains
sections open to members and nonmembers. Areas open to nonmembers focus on meetings
and events, standards, GMP/QS, publications, certification, employment, awards,
and relevant links. Brief news stories are headlined on the main page and updated
frequently.
Established in 1973, the Association
of Medical Diagnostics Manufacturers (AMDM) is a nonprofit trade association
that serves as a resource for education and information on compliance issues
for member companies, and as an interface between member companies and FDA.
Originally, membership was limited to manufacturers and distributors of prepared
microbiological media. Today, membership includes suppliers and consultants
to the in vitro diagnostics industry and companies of all sizes that manufacture
and distribute in vitro diagnostic products, including cell cultures and cell
culture media, immunology and immune status test products, antigen and microbial
detection products, and toxicological products.
ASQ Biomedical Division
has as its mission to "promote the awareness and use of quality principles,
concepts, and technologies in the biomedical community." Information on educational
programs and upcoming events, selected publications (mostly in PDF), job listings,
and a links section can be found on the site. The publications page lists a
number of documents relating to FDA's QSIT program.
The purpose of the Biomedical
Engineering Society (BMES) is to promote the increase of biomedical engineering
knowledge and its utilization. BMES has several publications to keep members
informed of society activities and developments in the biomedical engineering
profession. The scientific journal Annals of Biomedical Engineering is published
monthly and presents original research. The BMES Bulletin, published quarterly,
presents science review articles, student chapter news, society and public policy
announcements, employment opportunities, and a calendar of conferences. BMES
holds annual spring and fall conferences for the presentation of technical papers
and conduct of society business. BMES sponsors student chapters at universities
throughout the country, and serves as the headquarters for Alpha Eta Mu Beta,
the national biomedical engineering honor society.
The Diagnostic Marketing Association is a nonprofit professional organization of nearly 700
marketing and management professionals involved in marketing diagnostics and
other medical products or services. The association offers seminars and an annual
conference, and it presents marketing excellence awards. Its quarterly publication
is The Diagnostic Insight.
The California Healthtech Institute
(CHI) is a statewide public policy research and advocacy organization for
Californias healthcare technology industry. CHIs members include
medical device, biotechnology, and pharmaceutical companies, as well as public
and private research institutions in California. The organization combines the
strengths of these industries to advocate state and federal policies that promote
scientific discovery and biomedical innovation. CHIs legislative priorities
include broadening state R&D tax incentives to reflect the special needs
of medical device innovators, ensuring patient access to new medical technologies,
and protecting confidentiality of medical information without hindering research.
The Clinical Ligand Assay Society
(CLAS) is a nonprofit international organization of more than 700 members
who have an interest in establishing and promoting high standards in the science
and application of ligand assay technology. The society encourages research,
the education of practitioners, and communication and cooperation among individuals
in medical, pharmaceutical, academic, and industrial laboratories. It publishes
the Journal of Clinical Ligand Assay, a laboratorian desk reference, and a newsletter,
and it holds regional and national annual meetings and educational seminars
and offers certification in the area of ligand and radio assay.
The Contract Packaging
Association is comprised of contract packagers, material suppliers, and
end-users. As of August '99, the site was still under construction, but plans
include a list of packaging industry links, an overview of the packaging field,
a discussion forum, classified ads, and a form that allows end-users to request
a bid for packaging services.
The Controlled Release
Society (CRS) is an international organization with the mission of advancing
the science and technology of chemical and biological delivery systems. The
society sponsors annual symposia, workshops, and short courses; publishes a
newsletter; and promotes education and student and local chapters.
ECRI, a nonprofit health-services
research agency and a collaborating center of the World Health Organization,
provides information to the healthcare community to support safe and cost-effective
patient care. ECRI is the worlds largest independent evaluator of medical
devices and maintains numerous databases on medical technologies. ECRI publishes
the Health Devices Sourcebook, an annual directory of medical device manufacturers
and equipment; the Health Devices International Sourcebase, an international
electronic database of medical product manufacturers and the types of products
they supply; and the Healthcare Product Comparison System on CD-ROM, an international
database of capital medical equipment, including brand-name product specifications
and overviews of various technologies.
The Edison BioTechnology Center
(EBTC) was established in 1987 to accelerate the growth of Ohios biotechnology,
biomedical, and healthcare-information software industries. EBTC works closely
with Ohios medical research institutions, biomedical/ biotechnical companies,
and community organizations to commercialize research, form companies, and promote
the Ohio industry to regional and national audiences. EBTC has offices in Cleveland,
Cincinnati, and Columbus.
The Edison Welding Institute (EWI)
is a leading engineering organization with more than 160 engineering, technical,
and support-staff personnel with expertise in virtually every welding and joining
technology for use with metals, ceramics, and plastics. EWI operates as a nonprofit
industrial consortium, working with its more than 400 member companies to provide
applied research, consultancy, training, and general technical support. Medical
manufacturers have used EWIs expertise to assess the weldability of nitinol;
develop processes for refractory metals such as platinum, platinum-iridium,
tungsten, and molybdenum; join dissimilar materials such as ceramics to stainless
steel; and assess the seal integrity of plastic materials.
The Electronic Industries Alliance
(EIA) is a national trade organization representing U.S. electronic manufacturers.
Committed to the competitiveness of the American producer, EIA represents the
entire spectrum of companies involved in the manufacture of electronic components,
parts systems, and equipment for communications, industrial, government, and
consumer uses.
The Electrostatic Discharge Association
is dedicated to advancing the theory and practice of electrostatic discharge
(ESD) avoidance. From an initial emphasis on the effects of ESD on electronic
components, the association is broadening its scope to include other areas such
as textiles and fully assembled electronic products. The association sponsors
educational activities, including symposia and regional tutorials to support
research and education in ESD.
The Ethylene Oxide Sterilization
Association (EOSA) is an organization of contract sterilizers, sterilizer
manufacturers, and related companies promoting the safe use and handling of
EtO for sterilization. This attractive site (apparently not updated often) contains
news releases, a member list, a calendar of events, and a brief list of links.
The European Surgical
Trade Association (ESTA) is an organization representing companies that
specialize in the import, distribution, marketing, and sale of medical products.
The sole purpose of the site is to provide contact information and links to
individual members in Belgium, Denmark, Finland, France, Great Britain, Greece,
Iceland, Ireland, Italy, The Netherlands, Norway, Poland, Portugal, Spain, and
Switzerland.
Previously known as the Food and Drug Law Institute, FDLI
is a nonprofit, educational organization founded in 1949. Its mission is to
advance the public health by providing a neutral forum for the critical examination
of the laws, regulations, and policies related to drugs, medical devices, other
healthcare technologies, and foods. FDLI accomplishes its mission through educational
seminars and workshops, audio- and videoconferences, publications and periodicals,
and through sponsorship of prestigious academic programs and symposia, internships,
and writing awards. FDLIs membership includes leading manufacturers, suppliers,
law firms, and other groups in the food, drug, cosmetics, dietary supplements,
medical devices and biologics industries.
The Food and Drug Law Institute.
In addition to membership and events information, this site includes a small
but useful list of links and an archive of key industry documents. Articles
from the Food and Drug Law Journal are listed in abstract form
but not provided in their entirety. FDLI also conducts (in conjunction with
the CDRH and similar organizations) a series of video conferences, which are
broadcast live to download sites throughout the country (viewers need to get
a satellite dish).
The Georgia Biomedical Partnership
is a private, nonprofit organization geared to leveraging the states existing
research facilities and biomedical infrastructure to attract new technologies
and companies to Georgia and to grow and expand existing industry. The groups
membership includes more than 200 member firms and 500 individuals from the
technology, academic, and general business communities, working together to
promote the development of the biomedical community in Georgia.
An industry-sponsored and supported nonprofit organization, the primary function
of the Health Industry Business
Communications Council (HIBCC) is to facilitate electronic communications
by developing appropriate standards for information exchange among all healthcare
trading partners.
A nonprofit association founded to encourage health industry growth in the
DallasFort Worth region, The
Health Industry Council of the DallasFort Worth Region gathers health
industry data about the area, promotes industry conferences and conventions,
and facilitates interaction among members of the healthcare community.
A national business trade association representing medical product distributors,
the role of Health Industry Distributors
Association (HIDA) is to enhance the business performance of its member
distributors. Through the annual Healthcare Distribution Conference and Expo,
HIDA brings together healthcare device manufacturers and distributors serving
the hospital, long-term care, physician or alternate-care, and imaging markets.
The Health Industry Group Purchasing
Association (HIGPA) is a nationally chartered trade association of healthcare
purchasing and supply chain organizations, including for-profit and non-for-profit
corporations, purchasing groups, associations, multihospital systems, and healthcare
provider alliances. The site offers information on upcoming events, organizational
leadership, a membership list, group press releases, healthcare links, and information
on the organization and how to join it.
The Health Industry Representatives
Association (HIRA) is a trade association of independent contractor sales
representatives in the healthcare industry.
The Healthcare Convention and
Exhibitors Association (HCEA) is an association of more than 600 organizations
dedicated to improving the quality and return on investment of healthcare conventions
and exhibitions.
The Web site of the Independent
Medical Distributors Association (IMDA) contains listings of specialty distributors,
membership information, news about IMDA conferences, and related documents,
including a copy of the group's suggested manufacturer/distributor contract.
Formed in 1991 as a trade association of companies and individuals involved
in the manufacture of medical devices in Indiana and composed of 40 corporate
and 16 associate members, Indiana
Medical Device Manufacturers Council Inc. (IMDMC) focuses on training and
education, legislative and regulatory issues, networking, and technology transfer.
Meetings include business development briefings, regulatory/legislative roundtables,
and presentations on industry topics. IMDMC produces a quarterly newsletter.
The Engineering in Medicine and Biology Society of the Institute
of Electrical and Electronics Engineers Inc. (IEEE) advances the application
of engineering sciences and technology to medicine and biology, promotes the
profession, and provides global leadership for the benefit of its members and
the public by disseminating knowledge, setting standards, fostering professional
development, and recognizing excellence. The field of interest of the IEEE Engineering
in Medicine and Biology Society is the application of the concepts and methods
of the physical and engineering sciences in biology and medicine. This covers
a broad spectrum ranging from formalized mathematical theory through experimental
science and technological development to practical clinical applications. It
includes support of scientific, technological, and educational activities.
The Institute of Environmental
Sciences and Technology (IEST) is an international professional organization
dedicated to enhancing process and product quality through the advancement of
controlled-environment technologies. The institute establishes and maintains
standards, recommended practices, educational programs, and communication forums.
Members contribute to environmental sciences in the areas of contamination control
in electronics manufacturing and pharmaceutical processes; design, test, and
evaluation of commercial and military equipment; product reliability issues
associated with commercial and military systems; and computer applications in
all areas of environmental science.
The Institute of Packaging Professionals
(IoPP) is the leading individual membership organization in the packaging
industry. The institute offers a full program of membership services, including
technical and news publications, professional development conferences, local
chapter activities, an annual packaging design competition, and the only professional
certification program in the packaging field.
The Massachusetts Medical
Device Industry Council (MassMEDIC) was formed in 1996 to promote the unique
interests of the Bay States vibrant and growing medical device community.
With more than 250 medical device companies, 56,000 industry workers, and annual
sales in excess of $4 billion, Massachusettson a per capita basisis
home to the largest concentration of medical device manufacturers in the United
States. Membership includes manufacturers, suppliers, teaching hospitals, research
institutions, and government agencies.
More than 220 healthcare-related companies and organizations from across the
industry are represented by Medical
Alley, a not-for-profit trade organization that serves as a collaborative
forum which promotes an environment to enhance innovation in healthcare. Through
its activities, the association provides forums for industry leaders to share
perpectives and work together to improve the quality of patient care and reduce
the rate of increase in healthcare costs. Medical Alleys activities include
advocating at the state and federal levels, providing educational programs and
seminars on important healthcare issues, and assembling leaders from across
the industry to find solutions to industry-wide concerns.
The Medical Device
Manufacturers Association (MDMA) is a national association based in Washington,
DC, that represents and serves nearly 130 independent manufacturers of medical
devices, diagnostic products, and healthcare information systems. MDMA seeks
to improve the quality of patient care by encouraging the development of new
medical technologies and fostering the availability of beneficial innovative
products in the marketplace.
The Medical Marketing Association
(MMA) provides personal, professional, and educational growth opportunities
to promote excellence in the marketing of pharmaceuticals, diagnostics, biologics,
and devices. The associations 1000 members are from pharmaceutical, diagnostics,
biologics, and device companies, and the agencies and suppliers serving them.
There are regional chapters nationwide that provide educational activities.
Founded in 1996, the Medical
Technology Leadership Forum (MTLF) is a nonprofit membership organization
designed to educate providers, policymakers, and the public about critical issues
concerning the development of medical technology. MTLF members consist of bioengineers,
physicians, research institutions, manufacturers, and patient organizations.
Medtech1.com, a joint
production between Body1 Inc., a consumer-focused healthcare portal, and The
Advanced Medical Technology Association (AdvaMed),
offers information tailored for both consumers and industry professionals on
the latest advances in medical technology. The site also includes breaking news;
information on over 500 different medical conditions, procedures, and diagnostic
tools; information on companies in the medical technology arena; and an Advocacy
Center.
The Michigan Medical Device Association
(MMDA) was formed in 1993 with the mission to promote and strengthen the
medical device industry in Michigan. It sponsors training seminars and a luncheon
speaker series; is active in the areas of government relations, networking,
and business development; and acts as a clearinghouse of information of interest
to members. It also sponsors the only statewide industry trade show every year,
publishes a bimonthly association newsletter and a membership directory, has
launched a home page on the Internet, and works with other associations in the
region to enhance the visibility of its members.
The Motor and Motion Association
(SMMA) is a North American association with a global focus on electric motors,
their control, and application. It serves as the principal voice of the industry
and provides a forum to develop, collect, and disseminate technical and management
knowledge. Current membership is 200 companies including manufacturers of motors,
controls, materials, and components; media; universities; and consultants. In
addition to a spring management conference and a fall technical conference,
SMMA offers motor and control design and application courses and seminars.
Through its Diagnostic Imaging and Therapy Systems Division, the National
Electrical Manufacturers Association (NEMA) lobbies and gathers information
for manufacturers of medical imaging and therapy equipment. The division also
works with imaging and therapy equipment manufacturers to represent their views
to Congress and FDA. The division is divided into several groups (nuclear medicine,
x-ray equipment, magnetic resonance imaging, ultrasound, radiation therapy,
and medical imaging informatics) to provide detailed information on technological,
business, and legislative development. The association is also active in developing
voluntary standards for the imaging and therapy device industry.
The National Fluid Power Association
consists of 245 U.S. and multinational manufacturers of hydraulic and pneumatic
products and systems.
The New Mexico Biotechnology
& Biomedical Association, established in 1994, brings together the New
Mexico and El Paso biotechnical and biomedical industry, researchers from universities
and federal laboratories, investors, and other service providers specializing
in support to the life science industry. With nearly 400 participants and 100+
members, the association represents a diverse group of bioscience businesses
including diagnostics, therapeutics, medical device, genomics, and bioinformatics
companies. Informational lunch meetings are held bimonthly, and directories
of industry and association participants are published annually.
The Packaging Machinery Manufacturers
Institute (PMMI) is a national trade association whose nearly 500 members
manufacture packaging and packaging-related converting machinery in the United
States and Canada.
The PDAAn International
Association for Pharmaceutical Science & Technology consists of more
than 10,500 scientists involved in the development, manufacture, quality control,
and regulation of pharmaceuticals and related products. The mission of the association
is education and information sharing in practical applications of pharmaceutical
technology. In addition to presenting educational conferences and hands-on laboratory
courses, the association publishes technical reports, a scientific journal,
and a newsletter on industry and regulatory issues.
The Radiological Society of North
America (RSNA) is an association of 30,000 radiologists and physicists in
medicine dedicated to education in the science of radiology.
Founded in 1976, the Regulatory
Affairs Professionals Society (RAPS) is an international organization of
regulatory professionals. The society has grown to nearly 8000 members worldwide,
serving individuals in the pharmaceutical, medical device, biologic, biotechnology,
and related areas. The societys goals are to facilitate the exchange of
ideas, to foster cooperation among regulatory professionals in industry and
government, and to provide continuing education in regulatory affairs.
The Society for Biomaterials
promotes advances in biomedical materials research and development through cooperative
research, educational programs, clinical applications, and professional standards
in the biomaterials field.
The Society for the Advancement
of Material and Process Engineering (SAMPE) is an international professional
member society that provides information on materials and processing technology
via technical forums, journal publications, and books in which professionals
in the field can exchange ideas and air views. The society provides a forum
for scientists, engineers, and academicians.
The Society of Manufacturing Engineers
(SME) is the worlds leading professional society serving the manufacturing
industry. Through its publications, expositions, professional development resources,
and member programs, SME influences more than 500,000 manufacturing executives,
managers, and engineers. Founded in 1932, SME has some 60,000 members in 70
countries and supports a network of hundreds of chapters.
The Society of Plastics Engineers
is dedicated to helping plastics professionals attain higher professional status
through increased scientific, engineering, and technical knowledge. The society
has more than 35,000 members worldwide involved in engineering, design, production
and processing, research and development, consulting, marketing and sales, purchasing,
education, and all levels of management.
Founded in 1937, the Society
of the Plastics Industry Inc. (SPI) is the trade association representing
one of the largest manufacturing industries in the United States. Its 1700 members
represent the entire plastics industry supply chain, including processors, machinery,
and equipment manufacturers and raw-material suppliers. The U.S. plastics industry
employs 1.5 million workers and provides $304 billion in annual shipments.
The SPIEThe International
Society for Optical Engineering is an international nonprofit technical
society dedicated to advancing the profession of optical engineering and promoting
the engineering, scientific, and commercial development and application of optical,
photonic, imaging, and optoelectronic technologies through its meetings, publications,
education, and communications programs.
The Surfaces in Biomaterials
Foundation brings together those who share the common goal of participating
in the future of surface biomaterials research. The foundation exists to ensure
sponsorship of workshops and symposia, to further the exchange of information
and ideas within the surface science and biomedical communities, to help in
understanding of interfacial problems common to many researchers and development
engineers, and to provide a forum that allows interaction and dissemination
of surface and interfacial information.
Although the Southern
California Biomedical Council is a local organization, the group's Web site
contains a good deal of useful information for biotech companies all over. Notable
features include a page of regulatory and engineering articles covering topics
such as GMPs, design controls, ISO certification, and CE marking.
The U.S.-ASEAN Council,
a national membership organization, represents private-sector interests in ASEAN
(the Association of Southeast Asian NationsBrunei, Indonesia, Malaysia,
Philippines, Singapore, Cambodia, Laos, Burma, Thailand, and Vietnam). The council
and its corporate members are committed to promoting and expanding U.S.-ASEAN
trade and investment, fostering the growth of business ties, and implementing
programs that assist U.S. and ASEAN companies in identifying commercial opportunities.
The mission of the Ultrasonic
Industry Association Inc. (UIA) is to change the world of medicine and industry
through the use of ultrasonics. It provides access to educators, researchers,
engineers, users, products, and applications. Membership benefits include discounted
registration to symposia, subscription to UIAs Vibration newsletter, information
on applications as well as equipment and service sources, and updates on regulations
and standards.
An independent, not-for-profit safety testing and certification organization
established in 1894, Underwriters
Laboratories Inc. (UL) evaluates and certifies products, materials, and
systems to various safety standards. UL services include granting the UL mark
for the U.S. and Canada, notified body assessment of compliance with EU directives,
CE marking for medical and in vitro diagnostic devices, FDA 510(k) third party
review, EMC testing, and quality system registrations to ISO 9000, EN 13485,
and ISO 46000. UL offers local and international assistance: in Europe, phone
+44 1483 302130; in Asia, e-mail ul.jp@jp.ul.com.
The Utah Life Science
Association (ULSA) is a nonprofit organization formed to promote the general
welfare of life science industries in Utah and the nation. It was created to
accommodate the needs of businesses and organizations in several industry sectors,
including the biotechnology, medical device, diagnostic, and healthcare sectors.
Its mission is to develop and promote life science industries by bringing members
together in partnership to foster education at all levels; facilitate innovation,
excellence, and international competitiveness in products and services; gain
consensus for action; and handle matters relating to policy formation, legislation,
and regulations that affect these industries.
Women in Packaging
is an organization founded to promote the advancement of women in the packaging
industry. The site lists news, jobs, and events and has links to packaging organizations
and schools.

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