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March 20, 2013News for medical technology professionals

  Top Story 
 
  • Bipartisan support key in repealing device tax
    Medical-device companies are educating key Democrats to build support to repeal the 2.3% medical device tax that took effect in January. Events organized by trade groups such as AdvaMed, as well as company tours and a letter circulated among Senate Democrats last year, have helped the cause gain bipartisan support. Minnesota's senators have been talking with President Barack Obama to soften his stance as well. "I think that there has been some renewed understanding on the president's part," said Sen. Al Franken, D-Minn. The New York Times (tiered subscription model) (3/19) LinkedInFacebookTwitterEmail this Story
CAPA Violations Still the Top Issue for FDA:
FDA inspectors view a firm's CAPA program as an indicator of how well or how poorly a firm has a handle on its overall operations.
Read more...
  Business & Market Trends 
 
  • Calif. heart device startup closes $25M financing round
    Topera Medical has obtained $25 million in a round of financing from unnamed backers. The San Diego startup is the maker of the FDA-cleared RhythmView 3D mapping device, which is used to deliver targeted therapy to the heart's electrical "hot spots" in patients with cardiac rhythm disorders. MassDevice.com (Boston) (3/18) LinkedInFacebookTwitterEmail this Story
 
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 
 
  
Eucomed represents the medical technology industry in Europe. Our mission is to make modern, innovative and reliable medical technology available to more people. AdvaMed and Eucomed partner on issues of mutual interest.
  • Welsh government opens $159M fund for life sciences firms
    The Welsh government has announced the launch of the Wales Life Sciences Investment Fund, which aims to promote job and business growth as well as boost the global profile of the biotech sector in that country. The fund, worth $159 million, is expected to help launch more Welsh medical device and diagnostic companies in the U.K. and international markets. Clinica (subscription required) (3/19) LinkedInFacebookTwitterEmail this Story
The New You Starts Here.
Designed for busy healthcare professionals, FIU's online Healthcare MBA is transformative. Graduates emerge ready for a leadership role in healthcare, with a clear vision of how to lead collaboratively and advance the business of healthcare. Classes begin Fall 2015. Start here.

  Science & Health 
 
  • Engineer uses 3D printing technology to improve prostheses
    3D printing will transform the medical device industry by enabling users to produce more comfortable prostheses, according to product development engineer Bilal Ghalib. His organization, the Global Entrepreneurship and Maker Space Initiative, seeks to bring such new technologies to the developing world. Ghalib created a better-fitting prosthetic leg for his cousin using 3-D printing. USA Today (3/17) LinkedInFacebookTwitterEmail this Story
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.

  Emerging Technologies 
  • Dune Medical's breast cancer device debuts in U.S.
    Dune Medical Devices has announced the U.S. release of its MarginProbe System, which was approved by the FDA in January. The University of California, Irvine Medical Center was the first in the U.S. to deploy the system, which is used for tissue evaluation during early-stage breast cancer procedures. Boston Herald (3/19) LinkedInFacebookTwitterEmail this Story
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  Government & Regulatory 
  • NuVasive gets warning letter over spinal implant marketing
    The FDA has issued a warning letter to NuVasive over certain marketing language regarding the company's Affix Spinous Process Plate System. NuVasive said in a regulatory filing that it is already beginning to address the issue, and the company stressed to its shareholders that there were no manufacturing problems that needed to be addressed. MassDevice.com (Boston) (3/19) LinkedInFacebookTwitterEmail this Story
Is Pricing Low Your Strategy to Success? Think again.
Pricing is the heart of a business. It affects everything you do and is affected by everything you do. Economists talk of supply and demand as key factors behind pricing—successful entrepreneurs manipulate demand by making their products more desirable. These six steps will help you determine the right price for your product or service, read the article and learn how to get pricing right.

AdvaMed News 
  • Navigating the SEC's New Conflict Minerals Disclosure Requirements
    Thursday, April 11
    Webinar, 1:00 p.m. - 2:00 p.m. EST
    The SEC recently approved the much-debated conflict minerals due-diligence disclosure rules that were originally developed in the Dodd-Frank Wall Street Reform and Consumer Protection Act. The rule requires public companies to disclose the use of any conflict minerals that “are necessary to the functionality or production of a product manufactured” or “contracted to be manufactured” by that company. While not banning the use of conflict minerals, it does require companies to assess their supply chains and publically disclose their use of the minerals. When your company is producing either components or finished medical devices for customers, you will need to understand the nuances of your supply-chain position in relation to the SEC's rule. Learn more about SEC’s rule in this comprehensive webinar. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
Learn more about AdvaMed ->About AdvaMed | Join | Courses | Events | Newsroom

 
Position TitleCompany NameLocation
Sales / Technical SpecialistKaneka Pharma America LLCNew York, NY
Sales Area Manager/Sales Rep of Neurovascular Intervention ProductsAsahi Intecc USA, Inc.Any location in US, CA
Sr.Regulatory Affaris AssociateMindray DS USA, Inc.Mahwah, NJ
Project Manager, Regulatory Affairs - Transfusion Medicine Johnson & JohnsonRaritan, NJ
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
Manager, HCL Regulatory & Quality ComplianceOwens & MinorLouisville, KY
Click here to view more job listings.

  SmartQuote 
Quality is not an act, it is a habit."
--Aristotle,
Greek philosopher


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