IVD Links
Last modified 4/3/2000The following organizations carry information of interest to IVD manufacturers on their Web sites. This list will be frequently verified, updated, and expanded. If you would like to see a particular site added to our list, or have any requests or suggestions, please let us know.
Adhesive and Sealant Council, Inc. (ASC)
7979 Old Georgetown Rd., Ste. 500, Bethesda, MD 20814
301/986-9700, fax 301/986-9795
A nonprofit, international 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. Offers semiannual conventions, technical short courses, government relations, statistics, and publications.
American Association of Bioanalysts (AAB)
917 Locust St., Ste. 1100, St. Louis, MO 63101-1413
314/241-1445, fax 314/241-1449
aab1445@primary.net
AAB is a national professional association that represents the interests of bioanalysts and community clinical laboratories.
American Association for Clinical Chemistry (AACC)
2101 L St. N.W., Ste. 202, Washington, DC 20037-1526
202/857-0717, 800/892-1400, fax 202/887-5093
A nonprofit, educational international organization with more than 11,000 members with a common interest in clinical laboratory science. Members specialize in fields such as clinical chemistry, biochemistry and immunology, molecular pathology, medical technology, clinical pathology, toxicology, and laboratory management. The association publishes books, a news magazine, and a journal; holds a clinical laboratory exhibition; offers educational programs; and is involved in government and regulatory affairs.
American Clinical Laboratory Association
1250 H St. N.W., Ste. 880, Washington, DC 20005
202/637-9466, fax 202/637-2050
acla@erols.com
ACLA encourages the highest standards of quality, service, and conduct among its members, and promotes awareness of the value of clinical laboratory services in preventing illness, diagnosing disease, and monitoring medical treatment.
American Electronics Association (AEA)
601 Pennsylvania Ave. N.W., North Bldg., Ste. 600, Washington, DC 20004
202/682-9110, fax 202/682-9111
Dedicated to strengthening the U.S. electronics and information technology industry's global competitiveness. The trade group, which represents some 3000 companies, offers member opportunities such as financial conferences, management programs, compensation surveys, group advantage member services, an industry statistics program, local council networking, and government relations programs. Its public affairs staff represents the association and industry in such areas as taxation, trade, education, government procurements, and the environment.
American Health Information Management Association
919 N. Michigan Ave. #1400, Chicago, IL 60611-1683
312/787-2672, fax 312/787-9793
mailto:info@ahima.org
As experts in clinical data and information management, the 38,000 professional members of the American Health Information Management Association (AHIMA) are vital to the healthcare industry. The unique knowledge and skills that AHIMA members possess are critical for classifying and analyzing health information, transitioning from paper to computer-based medical records, and enhancing data quality—all accomplished while maintaining patient confidentiality and information security. With a 70-year tradition of advancing quality healthcare through quality information, AHIMA is also instrumental in developing industry standards, advocating relevant legislation, and providing education in health information.
American Hospital Association
One North Franklin, Chicago, IL 60606
312/422-2000, fax 312/422-4700
American In Vitro Allergy/Immunology Society (AIAIS)
PO Box 341461, Bethesda, MD 20827-1461
301/263-0703, fax 301/263-0776
aiais@erols.com
AIAIS undertakes activities to educate its members about recent research affecting the diagnosis of allergic and immunologic diseases. The organization advocates the appropriate use of in vitro testing in the practice of allergy and immunology medicine, and offers a multidisciplinary forum for assessing advances in immunotherapy, pharmacotherapy, allergen avoidance, and immunomodulating agents
American Medical Association
515 North State St., Chicago, IL 60610
312/464-5000, fax 312/464-5839
American Medical Association is a voluntary service organization of physicians—nearly 300,000 from every segment of medicine—whose mission is to promote the science and art of medicine and betterment of public health. It was founded in 1847.
American Medical Group Association
1422 Duke St., Alexandria, VA 22314
703/838-0033, fax 703/548-1890
American National Standards Institute (ANSI)
11 W. 42nd St., New York, NY 10036
212/642-4900, fax 212/398-0023
American Society for Clinical Laboratory Science (ASCLS)
7910 Woodmont Ave., Ste. 530, Bethesda, MD 20814
301/657-2768, fax 301/657-2909
ascls@ascls.org
A large nonregistry professional association for nonphysician clinical laboratory professionals. Its 20,000 members include hematologists, phlebotomists, immunologists, immunohematologists, clinical chemists, microbiologists, managers, and educators.
American Society for Microbiology (ASM)
1325 Massachusetts Ave., NW, Washington, DC 20005-4171
202/737-3600, fax 202/942-9346
ASM is the oldest and largest life science membership organization in the world, with more than 40,000 members representing 24 disciplines of microbiological specialization plus a division for microbiology educators. ASM members have many common goals, including the desire for professional improvement through ASM journals, books, meetings, and other society activities. ASM members help to promote a better understanding of the importance of microbiology today and in the future.
American Society of Clinical Pathologists (ASCP)
2100 W. Harrison St., Chicago, IL 60612-3798
312/738-1336, 800/621-4142, fax 312/850-8800
cprc@ascp.org
Founded in 1922, ASCP is a not-for-profit medical society organized exclusively for educational, scientific, and charitable purposes. Serving as an educational resource, its mission is to promote public health and safety through appropriate application of pathology and laboratory medicine. The society is the largest pathology organization in the world, with a membership of 11,000 pathologists and other physicians and 66,000 laboratory professionals.
American Society of Cytopathology (ASC)
400 W. 9th St., Ste. 201, Wilmington, DE 19801
302/429-8802, fax 302/429-8807
asc@cytopathology.org
Founded in 1951, ASC is a national professional society of physicians, cytotechnologists, and scientists who are dedicated to the cytologic method of diagnostic pathology. The society sponsors an annual scientific conference, interim updates and workshops, a monthly teleconference, and publications. The society is responsible for ensuring the accreditation status of schools of cytotechnology, and offers a voluntary laboratory accreditation program.
AOAC International
481 N. Frederick Ave., Ste 500, Gaithersburg, MD 20877-2417
301/924-7077, fax 301/924-7089
aoac@aoac.org
An independent association of scientists and organizations in the public and private sectors devoted to promoting methods validation and quality measurements in the analytical sciences.
ASQ
P.O. Box 3005, Milwaukee, WI 53201-3005
414/272-8575, 800/248-1946, fax 414/272-1734
asq@asq.org
Founded in 1946, the 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 140,000 individuals and 1100 sustaining members.
Association for the Advancement of Medical Instrumentation (AAMI)
3330 Washington Blvd., Ste. 400, Arlington, VA 22201-4598
703/525-4890, 800/332-2264, fax 703/276-0793
customerservice@aami.org
AAMI is the preeminent developer of national and international medical device standards worldwide, as well as a primary source of quality systems information and education. The Association is an alliance of nearly 7,000 diverse professionals united by the common goal of increasing the safety and effectiveness of medical devices. Members include medical device manufacturers; clinical and biomedical engineers and technicians, physicians, nurses, and other health care professionals; researchers; educators; distributors; and government representatives. AAMI fulfills its mission through standards development; publication of technical documents, periodicals, books, and software; conferences; in-depth training programs, and professional certification programs.
Association of British Health Care Industries (ABHI)
St. George's House, 195-203 Waterloo Rd., London, SEI 8WD, UK
+44 171 7873060, fax +44 171 787 3061
enquiries@abhi.org.uk
The UK trade association for the medical device and systems industries. Members include manufacturers, distributors, and associated service companies.
Association of Medical Diagnostics Manufacturers (AMDM)
Columbia Square, 555 13th St. N.W., 7W-404, Washington, DC 20004-1108
202/637-6837, fax 202/637-5910
info@amdm.org
Established in 1973, 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 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.
Australian Diagnostic Manufacturers Association (ADMA)
PO Box 2001, East Ivanhoe, Victoria, 3079, Australia
+61 3 94576520, fax +61 3 94583889
qna@bigpond.com.au
ADMA is the industry organization for Australian companies involved in producing diagnostic test systems for the international market. The association focuses on promoting Australian diagnostic products at all levels, from OEMs to end-users. ADMA's functions include maintenance of relationships with the international scientific community, liaison with overseas government and industry groups, and staging of international exhibitions.
Biomedical Marketing Association
10293 N. Meridian St., Ste. 175, Indianapolis, IN 46290
317/816-1640, fax 317/816-1633
mfw@wardmanage.com
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, an annual conference, a marketing educational conference, and presents marketing excellence awards, quarterly publication, The Diagnostic Insight.
Biotechnology Industry Organization (BIO)
1625 K St., NW, Ste. 1100, Washington, DC 20006-1604
202/857-0244, fax 202/331-8132
info@bio.org
BIO represents companies, academic institutions, and state centers engaged in the development of biotechnology products and services in the areas of biomedicine, diagnostics, agriculture, energy, environmental, and industrial applications.
BloodLine: The Online Hematology
Resource
A site targeted at hematology professionals. Hematology research information and industry resources include current blood-related articles, CME offerings, grants and fellowships, links, meetings, organization information, publications for sale, and want ads.
British In Vitro Diagnostics Association (BIVDA)
1 Queen Anne's Gate, London, SW1H 9BT, UK
+44 171 9574633, fax +44 171 9574644
bivda@vbivda.co.uk
BIVDA is the United Kingdom's national trade association for companies involved in the IVD industry. The association represents the interests of the UK diagnostics industry to the European Diagnostics Manufacturers Association (EDMA) which in turn represents the European IVD industry, particularly to the European Commission. The association conducts seminars and workshops for both members and nonmembers.
California Healthcare Institute (CHI)
1020 Prospect St., Ste. 310, La Jolla, CA 92037
858/551-6677, fax 858/551-6688
chi@chi.org
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: FDA reform, broadening state R&D tax incentives to reflect the special needs of medical device innovators, ensuring Medicare reimbursement for procedures involving investigational medical devices, and tort reform that ensures the availability of biomaterials to medical device manufacturers.
Clinical Laboratory Management Association (CLMA)
989 Old Eagle School Rd., Ste. 815, Wayne, PA 19087-1704
610/995-9580, fax 610/995-9568
CLMA is an international organization whose members are professionals responsible for laboratories and clinical services in hospitals and healthcare networks, group practices, and independent settings. Through conferences, seminars, publications, and research CLMA offers opportunities for the educational advancement needed to create skilled managers in clinical medicine.
Clinical Ligand Assay Society (CLAS)
3139 S. Wayne Rd., Wayne, MI 48184
734/722-6290, fax 734/722-7006
clas@clas.org
A nonprofit international organization of more than 800 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 a professional journal, manuals, and a newsletter; holds regional and national annual meetings and educational seminars; and offers certification in the area of ligand technology.
College of American Pathologists (CAP)
325 Waukegan Rd., Northfield, IL 60093-2750
847/832-7000, 800/323-4040, fax 847/832-8172
CAP is a medical society serving more than 15,000 physician members and the laboratory community throughout the world. It is the world's largest association composed exclusively of pathologists and is widely considered the leader in providing programs for laboratory quality improvement. CAP's mission is to represent the interests of patients, the public, and pathologists by fostering excellence in the practice of pathology and laboratory medicine worldwide.
Electronic Industries Alliance
2500 Wilson Blvd., Arlington, VA 22201-3834
703/907-7500, fax 703/907-7501
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.
European Committee for Electrotechnical Standardization (CENELEC)
Rue de Stassart 35, B-1050 Brussels, Belgium
+32 2 5196871, fax +32 2 5196919
general@cenelec.be
CENELEC is the European Committee for Electrotechnical Standardization. The members of CENELEC are the National Electrotechnical Committees of 19 European countries and there are 11 affiliate countries. Standards are developed in close co-operation with the International Electrotechnical Commission.
European Committee for Standardization (CEN)
Rue de Stassart 36, B-1050 Brussels, Belgium
+32 2 5500811, fax +32 2 5500819
infodesk@cenorm.be
Membership consists of standards institutions of the European Union and the nations of the European Free Trade Association and the Czech Republic. Standards are adopted by qualified majority voting and must be implemented by the European Standards bodies. They are voluntary in application. Many support EU policies (e.g. CE Marking for new approach directions).
European Confederation of Medical Devices Associations (EUCOMED)
Rue du Collège St. Michel 17, Box 8, B-1150 Brussels, Belgium
+32 2 7722212, fax +32 2 7713909
eucomed@eucomed.be
Members include European manufacturers and distributors of medical devices and accessories, excluding active implantable medical devices, in vitro diagnostic devices, active capital equipment, and optical and emergency equipment.
European Diagnostic Manufacturers Association (EDMA)
Rue de Collège Saint-Michel 17-23, Box 7, B-1150 Brussels, Belgium
+32 2 7722225, fax +32 2 7722329
edma@edma-ivd.be
Established in 1979, EDMA is a nonprofit confederation of diagnostic manufacturers and diagnostic national associations representing the pan-European interests of its members.
FDLI
1000 Vermont Ave. N.W., Ste. 200, Washington, DC 20005-4903
202/371-1420, 800/956-6293, fax 202/371-0649
comments@fdli.org
Composed of more than 480 manufacturers, suppliers, law firms, consultants, and other organizations. FDLI is a nonprofit educational organization dedicated to improving the understanding of the laws, regulations, and policies affecting the food, drug, medical device, and biologics industries. FDLI is neutral, non-partisan, and does not lobby. The organization, once known as the Food and Drug Law Institute, nows uses FDLI as its complete name.
Health Industry Manufacturers Association (HIMA)
1200 G St. N.W., Ste. 400, Washington, DC 20005-3814
202/783-8700, fax 202/783-8750
hima@himanet.com
HIMA is a Washington, DC-based trade association and the largest medical technology association in the world. HIMA represents more than 800 manufacturers of medical devices, diagnostic products, and medical information systems. HIMA's members manufacture nearly 90% of the$55 billion of health care technology products purchased annually in the United States, and more than 50% of the $130 billion purchased annually around the world.
Independent Reagent Manufacturers Association (IRMA)
845 Ave. G East, Arlington, TX 76011
817/640-0965, fax 817/649-2461
IRMA is a coalition of in vitro diagnostic manufacturers that work together with regulatory agencies, legislators, and other trade associations to address issues that affect the industry. There are no dues associated with membership.
Indiana Medical Device Manufacturers Council, Inc.
1908 E. 64th St., South Dr., Indianapolis, IN 46220
317/257-8558, fax 317/259-4191
Formed in 1991 as a trade association of companies and individuals involved in the manufacture of medical devices in Indiana. Composed of 40 corporate and 16 associate members, 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.
Institute of Electrical and Electronics Engineers, Inc. (IEEE)
445 Hoes Ln., P.O. Box 1331, Piscataway, NJ 08855-1331
732/981-3433, fax 732/981-1769
emb-exec@ieee.org
The Engineering in Medicine and Biology Society (EMBS) of the Institute of Electrical and Electronics Engineers, Inc. (IEEE) is the largest biomedical society in the world with more than 9,000 members worldwide. The Society engages in technical, educational and professional activities that advance the theory and practice of electrotechnology, contribute to the lifelong professional and personal development of its members, and advance the profession. IEEE EMBS members transform scientific and technological advances into practical and safe products and procedures that enhance the quality of life.
International Electrotechnical Commission (IEC)
Rue de Varembé 3, B.P. 131, CH-1211 Geneva 20, Switzerland
+41 22 9190211, fax +41 22 9190300
info@iec.ch
An organization creating international standards for the electrical and electronic industries, IEC has developed a series of standards specifically for electromedical equipment. Standards can enable electrical and electronic equipment to work together no matter where it is designed, manufactured, assembled, or used. IEC international standards are used in more than 100 countries.
International Organization for Standardization (ISO)
1 Rue de Varembé, CH-1211 Geneva 20, Switzerland
+41 22 7490111, fax +41 22 7333430
central@iso.iso.ch
A worldwide federation of national standards bodies from some 120 countries that promotes the development of standardization and related activities to facilitate the international exchange of goods and services and to develop intellectual, scientific, technological, and economic cooperation. ISO's technical committees, working groups, and ad hoc study groups represent the viewpoints of manufacturers, vendors and users, engineering professions, testing laboratories, public services, governments, consumer groups, and research organizations in each member country.
International Society for Optical Engineering (SPIE)
PO Box 10, Bellingham, WA 98227-0100
360/676-3290, fax 360/647-1445
spie@spie.org
An international technical society dedicated to advancing engineering, scientific, and commercial applications of optical, photonic, imaging, electronic, and optoelectronic technologies. Its members are engineers, scientists, and users interested in the development and reduction to practice of these technologies. SPIE provides the means for communicating new developments and applications information to the engineering, scientific, and user communities through its publications, symposia, education programs, and on-line electronic information services.
Joint Council of Immunohistochemical Manufacturers (JCIM)
PO Box 260051, Crestwood, MO 63126
650/697-3600, 800/521-8956, fax 650/697-0339
jcim1@hotmail.com
An association that advocates collectively the interests of its members in regulatory, clinical, and scientific matters concerning antibodies and molecular biology reagents and related products. JCIM includes manufacturers of IVD devices employing related technology, relevant contract research organizations, and others.
Medical Device Manufacturers Association (MDMA)
1900 K St. N.W., Ste. 300, Washington, DC 20006
202/496-7150, fax 202/496-7756
mdmaininfo@medicaldevices.org
The Medical Device Manufacturers Association (MDMA) is a national trade association based in Washington, DC that represents nearly 130 independent manufacturers of medical devices, diagnostic products and health care information systems. MDMA seeks to improve the quality of patient care by encouraging the development of new medical technology and fostering the availability of beneficial innovative products. To achieve these goals, MDMA represents its members' collective interests before the United States Congress, the Food and Drug Administration (FDA), and other federal agencies that develop or implement policies that affect the medical device industry.
Medical Devices Canada (MEDEC)
401 The West Mall, Ste. 510, Toronto, ON M9C 5J5, Canada
416/620-1915, fax 416/620-1595.
medec@medec.org
Established in 1973, the non-profit trade association has over 125 members representing manufacturers and distributors of medical devices in Canada. MEDEC has three action groups focused on regulatory, marketing, and professional development issues. Four sector groups: cardiovascular, diagnostic, orthopaedic, and ophthalmic.
Medical Group Management Association
104 Inverness Terrace East, Englewood, CO 80112-5306
303/799-1111, 888/608-5601, fax 303/643-4439
National Institute of Standards and Technology (NIST)
Inquiries Unit, Gaithersburg, MD 20899-0001
301/975-NIST, fax 301/926-1630
inquiries@nist.gov
As an agency of the U.S. Department of Commerce's Technology Administration, NIST's primary goal is to promote U.S. economic growth by working with industry to develop and apply technology, measurements, and standards. Its major programs are: a rigorously competitive Advanced Technology Program that provides cost-shared grants to industry for development of high-risk technologies with significant commercial potential; a grassroots Manufacturing Extension Partnership that helps small and medium-sized companies adopt new technologies; a strong laboratory effort planned and implemented in cooperation with industry and focused on measurements, standards, evaluated data, and test methods; and a highly visible quality outreach program associated with the Malcolm Baldrige National Quality Award.
National Medical Association
1012 10 St., NW, Washington, DC 20001
202/347-1895, fax 202/842-3293
National Medical Device Coalition (NMDC)
1900 K. St., NW, Ste. 300, Washington, DC 20006
202/496-7150, fax 202/496-7756
NMDC is a union of 10 regional and product-specific groups dedicated to reforming FDA's product approval process.
NCCLS
940 West Valley Rd., Ste. 1400, Wayne, PA 19087-1898
610/688-0100, fax 610/688-0700
info@nccls.org
An organization of volunteer experts working to define procedures to improve the products and services of the patient testing community. Members include laboratorians, clinicians, and representatives of healthcare institutions, professional societies, government agencies, public health laboratories, industry, and international organizations. The organization was formerly known as the National Committee for Clinical Laboratory Standards.
New Mexico Biotechnology & Biomedical Association
851 University Blvd. S.E., Ste. 200, Albuquerque, NM 87106
505/272-7900; fax 505/272-7300
andeada@unm.edu
The New Mexico Biotechnology & Biomedical Association, established in 1994, brings together the New Mexico and West Texas biotechnical and biomedical industry, researchers from universities and federal laboratories, investors, and other service providers specializing in support to the life science industry.
New York Biotechnology Association, Inc.
25 E. Loop Rd., Stony Brook, NJ 11790
516/444-8895; fax 516/444-8896
The New York Biotechnology Association is a nonprofit membership association representing 226 bioscience technology companies, world-class research institutes, and related professional services in New York state and the tri-state region. Its mission is to help existing biotechnology companies grow while also helping to create the conditions needed for new companies to form.
Regulatory Affairs Professionals Society (RAPS)
12300 Twinbrook Pky., Ste. 350, Rockville, MD 20852-1606
301/770-2920, fax 301/770-2924.
raps@raps.org
An international organization of regulatory professionals. Founded in 1976, the society has grown to more than 7,000 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
13355 10th Ave. North, Ste. 108, Minneapolis, MN 55441-5510
612/543-0908, fax 612/545-0335
member@biomaterials.org
A professional society that promotes advances in biomedical materials research and development through cooperative research, educational programs, clinical applications, and professional standards in the biomaterials field.
Southern California IVD Network
An informal gathering of professionals working in Southern California's vibrant IVD industry. Members of the group meet quarterly to discuss current trends affecting the industry. Presentations and discussions of the group focus on regulatory, quality, and clinical issues.
Southwest Biomedical Coalition
851 University Blvd., SE, Ste. 200, Albuquerque, NM 87106
505/272-7900, fax 505/272-7300
wellborn@unm.edu
The Southwest Biomedical Coalition is a regional association of device manufacturers, researchers and related entities located in West Texas and the state of New Mexico. The organization sponsors a monthly educational meeting featuring guest speakers on technological and business issues of interest to the biomedical community. Members of the coalition include medical device manufacturers and their suppliers as well as researchers and other representatives of the public healthcare sector, universities and national laboratories, and the legal, banking, and finance sectors.
SPIE—The International Society for Optical Engineering
P.O. Box 10, Bellingham, WA 98227-0100
360/676-3290, fax 360/647-1445
spie@spie.org
SPIE 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.
Are there other helpful sites we should list here? Please fill us in.
