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January 3, 2013News for medical technology professionals

  Top Story 
ISO 13485 - Change? Do I Have To??
This white paper reviews the conundrum companies are experiencing if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system. The paper discusses the changes in ISO 13485, what and who the changes affect, and how companies can prepare for a more successful transition to the new standard. Download the whitepaper.
  Business & Market Trends 
  • NineSigma to assist AtriCure with technical approaches
    AtriCure, which develops devices to treat patients with atrial fibrillation, is partnering with NineSigma to look for new ways to address technical issues. The partnership is being funded through the Ohio Third Frontier Open Innovation Incentive Program, under which NineSigma was chosen to help middle-market firms grow through open innovation. Cincinnati Business Courier (12/31) LinkedInFacebookTwitterEmail this Story
  International Developments 
  • Increased globalization among key trends for medtech this year
    The industry likely will see more job cuts this year as companies attempt to offset the 2.3% medical device tax. The four other trends facing the industry this year are increased global market expansion, more opportunities for medtech firms to migrate into pharma-dominated areas, more mergers and a rise in billion-dollar deals, according to this article. Clinica (subscription required) (1/2) LinkedInFacebookTwitterEmail this Story
  Industry Insight 

  Science & Health 
  • Ignyta gets $5.5M boost to conduct trials of rheumatoid arthritis test
    Ignyta raised an additional $5.5 million in a Series B financing round, bringing its total funds raised in the round to $6 million. The company will use the money to launch clinical trials of its molecular-based diagnostic test for rheumatoid arthritis, and seek CLIA certification to support a launch late next year or in early 2015. Xconomy/San Diego (12/31) LinkedInFacebookTwitterEmail this Story
  Emerging Technologies 
  • Controlling a prosthesis? There's an app for that.
    Instead of having to change her prosthesis every time she engages in a different activity, Tara Butcher now wears the new Magellan leg, which recently became available in the U.S. Sensors in the foot enable microprocessors in the ankle to adapt to different types of terrain, and Butcher can make adjustments using an app in her smartphone. The app also shares information electronically with Butcher’s prosthetist. KNBC-TV (Los Angeles) (12/28) LinkedInFacebookTwitterEmail this Story
  Government & Regulatory 
  • Effort to repeal 2.3% device tax will continue, AdvaMed says
    The 2.3% medical device tax has taken effect after Congress reached a deal to prevent the "fiscal cliff" on Tuesday. The industry, however, has vowed to continue the push to repeal the levy, which AdvaMed President and CEO Stephen Ubl said has bipartisan support "premised on the recognition that the tax is costing jobs and threatening patient care." (Boston) (1/2) LinkedInFacebookTwitterEmail this Story
  • For more: Read the entire statement from AdvaMed regarding the fiscal cliff and the device tax. LinkedInFacebookTwitterEmail this Story
AdvaMed News 
  • 510(k) Submissions Workshop
    Monday, Feb. 25 -- Tuesday, Feb. 26
    Sheraton Crystal City, Arlington, Va.
    This interactive workshop, taught by industry experts and key personnel from the CDRH 510(k) staff, leads participants step by step through the regulatory guidelines, practical steps and strategic considerations for determining a product's regulatory route to market, identifying a predicate device, planning and assembling a 510(k) submission, interacting with the FDA during the review process, and dealing with post-clearance issues. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • Join the AdvaMed-MTLI LinkedIn group!
    Build close relationships with member companies, both small and large, and receive an intimate understanding of the key issues affecting innovation, access and the bottom line. Interact in discussions that leverage the leadership and expertise of the medical technology industry. This social group is full of key stakeholders, influencers and industry thought leaders as well as regulatory and policy experts from the FDA and CMS. Aside from practical learning opportunities, this LinkedIn group provides the premier opportunity to network with key players from virtually every aspect of the industry. Link to the AdvaMed MTLI LinkedIn group page. LinkedInFacebookTwitterEmail this Story
Learn more about AdvaMed ->About AdvaMed | Join | Courses | Events | Newsroom

Position TitleCompany NameLocation
IP Litigation Counsel - 001980Edwards LifesciencesIrvine, CA
Senior Director, Clinical Programs - Transcatheter Heart ValveEdwards LifesciencesIrvine, CA
Clinical Project ManagerEndologix, Inc.Irvine, CA
Physician Training Program ManagerEndologix, Inc.Irvine, CA
Click here to view more job listings.

Well done is better than well said."
--Benjamin Franklin,
American inventor and statesman

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