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[Reference] [Medical Device] [FDA-CDRH] [European Union] [Health Canada] [ISO] [Organizations]

Industry Organizations of Interest to Medical Device Manufacturers



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.


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. AdvaMed’s 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.

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.

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 Association’s 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.

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.

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 institute’s 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 principles—consensus, due process, and openness—are 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 institute’s U.S. National Committee to the IEC, the International Accreditation Forum (IAF), and several regional standards and conformity assessment organizations.

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.

American Society for Quality (ASQ)

Founded in 1946, 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.

American Society for Testing and Materials (ASTM)

A primary source of voluntary standards for materials, products, systems, and services, the 33,000 members 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.

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.

Biomedical Engineering Society (BMES)

The purpose 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.

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.

California Healthtech Institute (CHI)

is a statewide public policy research and advocacy organization for California’s healthcare technology industry. CHI’s 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. CHI’s 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.

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.

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.

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.


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 world’s 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.

Edison BioTechnology Center (EBTC)

was established in 1987 to accelerate the growth of Ohio’s biotechnology, biomedical, and healthcare-information software industries. EBTC works closely with Ohio’s 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.

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 EWI’s 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.

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.

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.

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.

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, 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. FDLI’s 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 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).

Georgia Biomedical Partnership

is a private, nonprofit organization geared to leveraging the state’s existing research facilities and biomedical infrastructure to attract new technologies and companies to Georgia and to grow and expand existing industry. The group’s 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.

Health Industry Business Communications Council (HIBCC)

An industry-sponsored and supported nonprofit organization, the primary function of is to facilitate electronic communications by developing appropriate standards for information exchange among all healthcare trading partners.

The Health Industry Council of the DallasヨFort Worth Region

A nonprofit association founded to encourage health industry growth in the Dallas–Fort Worth region,gathers health industry data about the area, promotes industry conferences and conventions, and facilitates interaction among members of the healthcare community.

Health Industry Distributors Association (HIDA)

A national business trade association representing medical product distributors, the role 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.

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.

Health Industry Representatives Association (HIRA)

is a trade association of independent contractor sales representatives in the healthcare industry.

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.

Independent Medical Distributors Association (IMDA)

The Web site of 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.

Indiana Medical Device Manufacturers Council Inc. (IMDMC)

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, 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.

Institute of Electrical and Electronics Engineers Inc. (IEEE)

The Engineering in Medicine and Biology Society 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.

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.

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.

Massachusetts Medical Device Industry Council (MassMEDIC)

was formed in 1996 to promote the unique interests of the Bay State’s 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, Massachusetts—on a per capita basis—is home to the largest concentration of medical device manufacturers in the United States. Membership includes manufacturers, suppliers, teaching hospitals, research institutions, and government agencies.

Medical Alley

More than 220 healthcare-related companies and organizations from across the industry are represented by, 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 Alley’s 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.

Medical Device Manufacturers Association (MDMA)

is a national trade association based in Washington, DC providing educational and advocacy assistance to innovative and entrepreneurial medical technology companies. Since 1992, MDMA has been the voice for smaller companies, playing a proactive role in helping to shape policies that impact the medical device innovator. This is accomplished by maintaining relationships with key Members of Congress, senior staff at FDA and CMS, and through the grassroots support of our members.

Medical Marketing Association (MMA)

provides personal, professional, and educational growth opportunities to promote excellence in the marketing of pharmaceuticals, diagnostics, biologics, and devices. The association’s 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.

Medical Technology Leadership Forum (MTLF)

Founded in 1996, 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.

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.

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.

National Electrical Manufacturers Association (NEMA)

Through its Diagnostic Imaging and Therapy Systems Division, 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.

National Fluid Power Association

consists of 245 U.S. and multinational manufacturers of hydraulic and pneumatic products and systems.

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.

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.

PDAヨAn 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.

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.

Regulatory Affairs Professionals Society (RAPS)

Founded in 1976, 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 society’s 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.

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.

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.

Society of Manufacturing Engineers (SME)

is the world’s 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.

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.

Society of the Plastics Industry Inc. (SPI)

Founded in 1937, 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.

SPIEラThe 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.

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.

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.

U.S.-ASEAN Council

a national membership organization, represents private-sector interests in ASEAN (the Association of Southeast Asian Nations—Brunei, 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.

Ultrasonic Industry Association Inc. (UIA)

The mission 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 UIA’s Vibration newsletter, information on applications as well as equipment and service sources, and updates on regulations and standards.

Underwriters Laboratories Inc. (UL)

An independent, not-for-profit safety testing and certification organization established in 1894, 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

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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