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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 
What if a significant amount of your sales are derived from off-label use of your product?
Off-label promotion and off-label use should not be confused. There are risk management precautions you can take. This quick "Ask and Expert" will help you understand the basics. Read More.

  International Developments 
White paper: Supply chain can drive future profits
Of healthcare executives surveyed, 89% say supply chain success is "extremely important" to achieving profitability goals over the next three years. Read the new white paper by Frost & Sullivan, "Why focusing on the supply chain is the key to growing customer relationships and winning in today's healthcare environment." Download it now for free.

  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. (3/7) LinkedInFacebookTwitterEmail this Story
2015 L.E.K. Strategic Hospital Priorities Study: Hitting an Inflection Point for Hospital Suppliers and MedTechs
The MedTech industry has hit an inflection point and opportunities abound for medical device companies to deliver broader solutions and innovative commercial models. In this Executive Insights, L.E.K. presents a hospital segmentation framework that illustrates four dimensions of changes affecting providers and defines six main areas of strategic focus to drive success for MedTechs going forward. Download White Paper Now

  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. (3/7) LinkedInFacebookTwitterEmail this Story
Time off boosts employee morale — and other pleasant surprises
New research reveals that a clearly articulated time-off policy that's fairly, transparently implemented improves employee productivity and morale —creating a happier, more loyal workforce for long term success.
Click here to read the White Paper

  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
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.

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

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