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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 is the FDA inspector looking for?
FDA inspections can be a significant source of anxiety for drug and device makers. In order to alleviate some of that anxiety, firms need to know what the FDA is looking for during inspections so they can better prepare for them and, thus, increase the likelihood of a positive outcome. This prerecorded webinar can benefit you. Read More.

  International Developments 
Don't lose access to your customer's facility. We can help.
Rep-Clear: Watermark's Solution for ensuring access to your customers. Rep-Clear includes our proprietary platform for tracking all items associated with a Rep and our professional support staff to provide individual service, ensuring all items are up to date and access to a facility is not lost. View common rep excuses.

  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
Penn State's Master of Health Administration
Continuing your education with our online MHA program helps you do more than just keep up with this complex field. With your new degree, combining core healthcare and business management principles, you can prepare for challenging leadership positions in the constantly evolving world of healthcare. Learn More

  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
  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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