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| Advamed | | www.advamed.com |
| 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. |
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| American Society for Quality (ASQ) | | www.asq.org |
| Serving quality professionals in the United States and worldwide. |
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| ASQ, Minnesota Section | mnasq@aol.com | www.mnasq.org |
| Serving quality professionals in the upper Midwest (Minnesota, North Dakata and parts of Iowa, South Dakota, and Wisconsin). |
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| ASQ, Biomedical Division | | www.asq.org/biomed |
| 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. |
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| ASQ, Food, Drug, & Cosmetic Division | | www.asq.org/fdc |
| 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. |
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| Economic Development Administration, University Center | eda@uwstout.edu | eda.uwstout.edu |
| The EDA provides service/assistance in management systems to regulated businesses-industry on ISO standards. |
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| FDA Sites | | |
| FDA Home Page | www.fda.gov |
| Center for Devices & Radiological Health (CDRH) | www.fda.gov/cdrh |
| Code of Federal Regulations (CFR) | www.access.gpo.gov/nara/cfr |
| 21CFR | www.fda.gov/cdrh/devadvice/365.html |
| DSMICA Home Page | http://www.fda.gov/cdrh/industry/support/ |
Federal Food, Drug, and Cosmetic Act
| www.fda.gov/opacom/laws/fdcact/fdctoc.htm |
| Global Harmonization Task Force | www.ghtf.org |
Medical Device Reporting Home Page
| www.fda.gov/cdrh/mdr/ |
| MEDWATCH | www.fda.gov/medwatch/index.html |
| Premarket Approval Information | http://www.fda.gov/cdrh/pmapage.html#search |
510(k) Information & Releasable Database
| http://www.fda.gov/cdrh/510khome.html |
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Joseph M. Juran Center for Leadership in Quality
| mailto:juran@csom.umn.edu | www.carlsonschool.umn.edu/jurancenter |
| Advancing the frontier of Quality in business applications, as well as pushing Quality principles into the broader society. |
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MBBNet, U of Minnesota Medical School
| | www.mbbnet.umn.edu |
| Minnesota's virtual biomedical and bioscience community. |
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| Life Science Alley (formerly MedicalAlley/MnBio) | | www.lifesciencealley.com |
| Recently merged. Medical Alley - a trade organization supporting Minnesota's health care industry. MNBIO-a trade organization serving biotechnology in Minnesota. |
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| The Biobusiness Alliance of Minnesota | | http://www.biobizmn.org/ |
| The BioBusiness Alliance of Minnesota™ is devoted to building the bioscience industry, retaining and creating jobs and economic growth, and positioning Minnesota as a global leader in biobusiness. |
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| Design of Medical Devices Conference | | http://www.me.umn.edu/dmd/ |
| Provide a forum to bring medical device designers, manufacturers, researchers, and representatives from the public sector together to share perspectives on medical devices. |
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| Biomedical Engineering Institute | | http://www.bmei.umn.edu/ |
| BMEI is an interdisciplinary research organization uniting engineering and health sciences faculty, and counterparts in the community to create new medical devices. |
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| Medsuds | | www.medsuds.com |
| A network of medtech, biotech and lif e science professionals. |
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| Minnesota Technology, Inc. | | http://www.minnesotatechnology.org/ |
| Providing consulting and business services, sponsor training and professional development events, and publish magazines and newsletters that combine strategic advice with technology to meet your quality, productivity and profitability goals |
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| PERIODICAL SITES | | |
| Compliance Engineering | leading compliance resource | www.ce-mag.com |
| MD&DI | medical device publicatioin | www.devicelink.com/mddi |
| Quality Digest | major trade publication | www.qualitydigest.com |
| The Auditor | newsletter | www.theauditoronline.com |
| The Gray Sheet | FDA Device News | www.thegraysheet.com |
| The Silver Sheet | FDA Quality News | www.thesilversheet.com |
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| Regulatory Affairs Professional Society (RAPS) | | www.raps.org |
| A worldwide member organization creating and upholding standards of ethics, credentialing and education for the regulatory affairs (RA) profession within the health product sector. |
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| American Society of Testing and Materials (ASTM) | | www.astm.org/BOOKSTORE/BOS/1301.htm |
| 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. |
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University of Minnesota
Biomedical Engineering Institute | bmei@umn.edu | www.bmei.umn.edu |
| Guide research projects through the many necessary steps required to take a project from conception to completion. The BMEI provides services for students, faculty, and industry. |
