Welcome to Biomedical Consortium!
The Biomedical Consortium, formerly the Biomedical Focus Task Group, a group of biomedical industry professionals from the Minnesota Section of the American Society for Quality, created this web site to help professionals and students find events, personal and professional networks, news, educational information, important links and other resources related to the industry. This site is an important place for biomedical professionals to enhance their skills, improve their marketability, and help bioscience and medical device organizations and businesses be more successful in a highly regulated industry. Review the menu to the left, and see what might interest to you. The Biomedical Consortium welcomes comments and suggestions. Please e-mail information@biomedicalconsortium.org to get a response from the task group. The Biomedical Consortium is a task group of Minnesota Section 1203, American Society for Quality. Its objectives are to inform persons, organizations and businesses associated with the biomedical industry of opportunities to learn about specific issues, new and existing regulations and standards, and pertinent quality-related tools and techniques. The Task Group also provides learning events as resources permit.
MDD 2010 – NOW WHAT?? Doing business in Europe? Guess what? Things are changing! The European Union’s Medical Device Directive (MDD) requirements are being revised effective in 2010. How are these changes going to affect your company as it strives to sell medical devices in Europe?
December 2, 2009 The Biomedical Consortium is sponsoring a half-day seminar on the proposed changes to the MDD to help medical device companies understand them. Participants will hear about the changes and have a chance to ask questions. The presenter will be Jeff Witte from notified body, BSI. Participants will receive 0.3 RU’s. Date: December 2, 2009
Place: Crowne Plaza Hotel, 2200 Freeway Blvd, Brooklyn Center
Time: 8:00 to 11:30 am
Presenter: Jeff Witte, BSI
Cost: $60 includes continental breakfast and seminar materials TO REGISTER CLICK HERE Medical Device Alliance: Process Validation Methods for Medical Devices that Promote Continuous Improvement Process validation and continuous improvement are an important part of a successful Medical Device Operation. Completing a process change or product improvement can prove to be a long and costly process, requiring multiple process validations. This course provides insight and tools for the risk based approach to process validation, which promotes continuous improvement throughout the product life cycle.
November 19th 2009 08:00 AM to 12:00 PM at Coloplast
Members $199.00
Non-Members $299.00
REGISTER FLYER
Announcing Nine New Seminars in 2009--2010 These are the new seminars that members and non-members can tentatively schedule:
2009 Planned Events:
ISO 13485/QSR Basics Workshop September 14 (Ziebell)
FDA “Hot Topics” October 28 (Philips)
2010 MDD Changes December (early)
2010 Planned Events (Jan to Jun 2010):
Risk Management w/Hazard Analysis Jan
CAPA Feb (Jacobs, Philips)
Root Cause Analysis Feb (soon after CAPA)
Process Validation April
Supplier Quality May (Fedock, Baumann)
Outsourced Processing May What's news?
You can read the top biomedical-quality news stories everyday on biomedicalconsortium.org, thanks to the addition of RSS-news pages. Members asked for more up-to-date news on the web site, and your news has arrived:
ASQ: News from the American Society for Quality about current events and quality programs
FDA: News from the FDA about medical devices and drugs
Healthcare and Science: Articles about medicine and science from the news media
If you want a sample of the news from the Biomedical Consortium Task group, the news media, the FDA, and ASQ, watch the scrolling news box here on the home page. Click on headlines that interest you! The news updates everyday. If you want a more in-depth review of today's news, open the news pages listed under the News link in the links menu on the left side of the home page. Read the news here today and everyday!
Check the Minneapolis--St. Paul job market!
The Minneapolis StarTribune provides RSS feeds from its employment section. In addition to adding RSS news pages to biomedicalconsortium.org, the Biomedical Consortium task group has added a job source. Look for the job source in the middle of the right column of the home page. The job source samples 100 jobs from the categories of technician, science, quality, medical technology, manufacturing, and biotechnology in the StarTribune employment section. Watch for new jobs daily or weekly, as soon as the newspaper publishes them!
CERTIFIED BIOMEDICAL AUDITOR
The Certified Biomedical Auditor (CBA) is a professional who understands the principles of standards, regulations, directives, and guidance for auditing a biomedical system. Is this cerification for you? For more information click here. To provide questions, feedback, comments, or suggestions about the Biomedical Consortium send an e-mail message to information@biomedicalconsortium.org or telephone Ralph Arnott at 651-633-0265. Additional information about the Minnesota Section 1203 can be found at their web site, http://www.mnasq.org/. Their newsletter, the BenchmarQ, contains current Section information, programs and placement listing. Meetings Schedules and Minutes (A password-protected link for the Biomedical Consortium task team.) |
