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March 8, 2013News for medical technology professionals

  Top Story 
 
Streamline Combination Product Development
This complimentary white paper from Novella Clinical explores combination product regulatory strategies - from classification to market clearance. Combination product sponsors can avoid numerous regulatory hurdles by downloading this white paper now: Clarifying the Regulatory Road for Combination Products.
  Business & Market Trends 
5 positive ways to respond to negative comments.
Social media is a great way to connect with your customers, but what do you do when the conversation takes a negative turn? With 5 tips, you can learn how to positively respond and help direct the conversation. Read the article and learn the 5 ways to respond positively.

  International Developments 
 
Clinical Trial Data Transparency Forum: Expert insights
Hear industry and academic thought leaders - from Duke Clinical Research Institute, GlaxoSmithKline, Eli Lilly and more - share valuable insight on their clinical trial data transparency and sharing initiatives. This video covers a number of key perspectives and trends.

  Science & Health 
  • CircuLite gains FDA approval for blood pump study
    The FDA has granted CircuLite investigational device exemption approval to launch a clinical study of its SYNERGY Circulatory Support System, which uses an implanted canula to pump oxygenated blood in the heart. The device could provide hard-to-treat terminal patients with a minimally invasive alternative to bypass or open-heart surgery. MedGadget.com (3/7) LinkedInFacebookTwitterEmail this Story
 
  Emerging Technologies 
  • Vital Images' TAVR planning app lands 510(k) clearance
    The FDA has cleared Vital Images, a Toshiba Medical Systems unit, to market a planning application for transcatheter aortic valve replacements. The CT TAVR planning app allows doctors to image and measure the vascular anatomies of patients with aortic vascular disorders to guide the diagnosis, treatment and follow-up planning process. HealthImaging.com (3/7) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
AdvaMed News 
  • Medical Device Complaints, MDRs and Reports
    Tuesday, May 7 – Wednesday, May 8
    Sheraton Crystal City, Arlington, Va.
    FDA personnel and expert industry faculty discuss the elements of an effective complaint management system, the FDA's expectation about trending complaints from non-U.S. markets, how to ensure that your electronic records database handling complaints complies with 21 CFR Part 11, how to investigate complaints to determine if they are MDRs, the do's and don'ts when informing the FDA of a product problem, and the FDA's involvement in health hazard evaluation and classification. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Sales Area Manager/Sales Rep of Neurovascular Intervention ProductsAsahi Intecc USA, Inc.Any location in US, CA
Associate CounselACell, Inc.Columbia, MD
Compliance Consultant 2DJO GlobalVista, CA
Director, Health Care ComplianceRTI BiologicsAlachua, FL
Accreditation ManagerAmerican Association of Tissue BanksMcLean, VA
REGULATORY AFFAIRS SPECIALISTMasimo CorporationIrvine, CA
Director of Global Infrastructure - 002196Edwards LifesciencesIrvine, CA
Manager, HCL Regulatory & Quality ComplianceOwens & MinorLouisville, KY
DIR OPERATIONS, Milpitas Site - 130000007RAbbott San Jose, CA
Biostatistician - Post Market Surveillance Johnson & JohnsonRaynham, MA
Click here to view more job listings.

  SmartQuote 
Hope never abandons you, you abandon it."
--George Weinberg,
American psychologist, writer and activist


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