Biomedical Consortium Resources

Included are links to organizations of potential interest associated with the biomedical industry. Note that other general quality-related links can be found under Resources on the home page of the Minnesota Section website.

Categories include:

Professional & Trade Organizations

Providing member medical technology innovators and companies with the advocacy, information, education and tangible solutions necessary for success in a world of increasingly complex medical regulations.
American Society for Quality (ASQ)
Serving quality professionals in the United States and worldwide.
ASQ, Biomedical Division
Serving medical device manufacturers and users, hospital and healthcare professionals, regulatory personnel, instrumentation producers and users, government agency personnel, and contractors, consultants and suppliers to these groups.
ASQ, Food, Drug, & Cosmetic Division
Members include quality control and assurance, regulatory and compliance, scientific, engineering, manufacturing, marketing and sales professionals from companies, industry consultants and service organizations concerned with food, pharmaceuticals, cosmetics and related products.
Life Science Alley
A trade organization supporting Minnesota’s health care industry.
The Biobusiness Alliance of Minnesota
The BioBusiness Alliance of Minnesota is a nonprofit organization with a focused mandate: to foster and cultivate the long-term viability of the state’s bioscience sector.
Manufacturers Alliance
We provide peer-to-peer training, education, and resources which allow manufacturers to continuously grow, improve, and stay competitive.
Regulatory Affairs Professional Society (RAPS)
A worldwide member organization creating and upholding standards of ethics, credentialing and education for the regulatory affairs (RA) profession within the health product sector.
American Society of Testing And Materials (ASTM)
Volume 13.01 of Standards from ASTM presents standards and tests for drugs and medical devices. ASTM Committee F04 on Medical and Surgical Materials and Devices has 800 members and meets twice annually.

FDA Links

FDA Home Page
Center for Devices & Radiological Health (CDRH)
Code of Federal Regulations (CFR)
DSMICA Home Page
Federal Food, Drug, and Cosmetic Act
Global Harmonization Task Force
Medical Device Reporting Home Page
Premarket Approval Information
510(k) Information & Releasable Database

Academia links

Economic Development Administration, University Center
The EDA provides service/assistance in management systems to regulated businesses-industry on ISO standards.
Joseph M. Juran Center for Leadership in Quality
Advancing the frontier of Quality in business applications, as well as pushing Quality principles into the broader society.
MBBNet, University of Minnesota Medical School
Minnesota’s virtual biomedical and bioscience community.
University of Minnesota Institute for Engineering in Medicine
An interdisciplinary research organization strengthening efforts between the schools of engineering and medicine at the University of Minnesota seeking to provide solutions to the regional medical device industry.
Design of Medical Devices Conference
Provide a forum to bring medical device designers, manufacturers, researchers, and representatives from the public sector together to share perspectives on medical devices.

Periodical Links

Compliance Engineering
leading compliance resource
medical device publication
Quality Digest
major trade publication
The Auditor
The Gray Sheet
FDA Device News
The Silver Sheet
FDA Quality News

Other links of interest

Medscape is a free full-service web site for physicians and other health care professionals of any specialty. Pick the specialty you want to join, and set up Medscape as the home page on your desk top. You will see news, reports, and presentations from your medical specialty. Search Medline and drug databases. Use your free Medscape mail box to send and receive e-mail messages.
Food and Drug Law Institute
Register for regulatory affairs courses through the Food and Drug Law Institute
McGraw-Hill’s AccessMedicine
Physicians and scientists pay a subscription fee to access the popular professional resource Harrison’s Online and other medical data and information resources. Harrison’s Online is a web resource for physicians and biomedical scientists that offers up-to-date professional information about disease.
FDC Reports
Subscribe to newsletters that will keep you updated about drug and medical device development and policies.
The Silver Sheet
Monthly publication delivering in-depth analysis of quality control and compliance issues for the device and diagnostic industries, plus updates on international standards and detailed summaries of FDA warning letters and recalls.
The Gray Sheet
Provides weekly, in-depth news and analysis of the medical device, diagnostics and instrumentation industries, including specialized coverage of FDA, reimbursement and legislative actions, product approvals and development efforts, technology assessments, and other business and related information.
Medical Design Online
Medical Design Online, a commercial web site, provides equipment and materials information for medical device manufacturers.
American Medical Association Doctor Finder
Find physicians throughout the United States with the AMA Doctor finder.
Center Watch Clinical Trials Listing
Center Watch provides resources for conducting clinical trials. Using the web site, you can identify trial sites for your study, look at the results of clinical trials, and help your patients understand your clinical trial.
Search the Studies
If you need to see the results of current clinical research studies, look up your area of interest on Search the Studies from the National Institutes of health.
European Confederation of Medical Devices Associations
When you want to understand the medical device policy makers in Europe, try the services of the European Confederation of Medical devices.
Medical Device Link
Purchase new materials and technology or look up news and publications about medical devices.
Medical Device Manufacturers Association
Influence medical device policy makers in the United States through the Medical Device Manufacturers Association.
Register your company on MedMarket and see yourself with other medical product manufacturers and suppliers in MedMarket’s Online Directories.
Medical Device Register
Look up medical device suppliers in this extensive online directory.
Centers for Disease Control and Prevention Diseases and Conditions
Browse “Diseases and Conditions” on the CDC web site and find and graphs.
ANSI-ASQ National Accreditation Board
Assesses and accredits certification bodies that demonstrate competence to audit and certify organizations conforming to management standards.
International Organization for Standardization (ISO)
International standards for business, government and society.
International Conference on Harmonisation
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.