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May 7, 2012News for medical technology professionals

  Top Story 
Selling your business? Here are 7 things you should do now.
If you're considering selling your business, you should be doing everything you can to get the best possible price. In just 7 simple steps you can improve your chances of attracting buyers and getting big bucks for your business. Read the article and learn the 7 steps.

  Business & Market Trends 
  • Bioscience incubator slated to open next month in Ariz.
    BioInspire, an incubator that aims to invest in biomedical device startups, is scheduled to launch next month at a 6,800-square-foot facility in Peoria, Ariz. The incubator is a collaborative effort among the Peoria City Council, Plaza Companies and BioAccel, and has an annual city funding estimated at $1.6 million over a three-year period. The Arizona Republic (Phoenix) (5/4) LinkedInFacebookTwitterEmail this Story
Effective Post-Market Clinical Follow-Up
Post-market surveillance including clinical follow-up, complaints, and vigilance are vital in ensuring compliance with the EU medical device directives, and are an essential component of a 13485 Quality Management System. Learn more about PMS and Vigilance. Visit the PMS Spotlight
  International Developments 
  • Smith & Nephew targets sevenfold growth in Brazil
    Smith & Nephew CEO Olivier Bohuon said in a recent investors' call that his company aims to grow its orthopedic device business in Brazil sevenfold and potentially generate more than $150 million in revenue there. To that end, the company has added a general manager role to oversee its Brazil operations, with plans to boost its presence in that country even more. (Boston) (5/4) LinkedInFacebookTwitterEmail this Story

Time and Attendance: The Core of Managing and Measuring Your Workforce
Based on data from Brandon Hall Group's 2014 Workforce Management Study, this paper explores the evolution of time and attendance, the impact of automation and integration, and the key role time and attendance solutions play in managing and measuring today's workforce. Read the Paper and Learn More

  Science & Health 
  • Study aims to test use of CT, blood assay in lung cancer diagnosis
    A trial being launched at National Jewish Health in Denver will combine the use of a low-dose CT scan and Oncimmune's EarlyCDT-Lung blood assay as a way to improve early-stage lung cancer detection. The four-year trial will involve 1,600 individuals ages 50 to 75 years and who have a history of smoking one pack a day for at least 20 years, among other criteria. (5/7) LinkedInFacebookTwitterEmail this Story
Combating Identity Theft in a Mobile, Social World
Mobile connectivity threats extend from consumers to the business environment. But who is really responsible for securing sensitive information? Smart business leaders are becoming proactive on the matter. Learn how to get protected in this white paper. Download the white paper now.

  Emerging Technologies 
  • Sanofi announces U.S. launch of iPhone-enabled glucometer
    Sanofi said its iBGStar device used to measure and transmit a patient's blood glucose readings to health care providers wirelessly is available commercially in the U.S. The device is billed as the first blood glucose meter to be approved by the FDA that is accessible on the iPhone or iPod touch. (5/4) LinkedInFacebookTwitterEmail this Story
How to Achieve IT Agility: A Survival Guide for IT Decision Makers
When business teams add new apps and services to already-strained networks, IT departments are accountable for making everything work. Is your team ready for this challenge? Read this eGuide to learn how IT teams are automating their networks, why they're utilizing Ethernet fabrics and SDN, and what success looks like as they regain network control and business relevance.

  Featured Content 

  Hot Topics 

Top five news stories selected by AdvaMed SmartBrief readers in the past week.

  • Results based on number of times each story was clicked by readers.
  Industry Service Providers 
  Government & Regulatory 
AdvaMed News 
  • Getting to Market in the EU: Making Sense of the Many EU Requirements for Clinical Data
    Tuesday, May 8
    Webinar, 12:00 p.m. - 1:00 p.m. EST
    With the recent medical device scandals in the EU, the commissioner has publicly requested tighter controls. Clinical evaluations are an area that have come under scrutiny in recent years, resulting in multiple changes in the regulations and standards, and creating additional potential consequences for manufacturers who are selling legacy devices or planning to introduce new models in the EU. Device manufacturers need to know what the new requirements are and how they may affect existing and new product certifications. In this live webinar, participants will have the opportunity to hear from the expert presenter, Dr. Dannhorn, on strategies for meeting the new requirements and have the opportunity to ask questions. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
  • Supplier Controls: Regulations and Best Practices Virtual Meeting
    Wednesday, June 6
    Virtual Conference, 10:00 a.m. - 4:00 p.m. EST
    Recent enforcement actions and several product-related tragedies highlight the risks of inadequate vendor selection and oversight, poor communication, misunderstanding of regulations and responsibilities, and a failure to apply the same risk-based approach to supplied components and services that one applies to one's own products and processes. This virtual conference brings together leading authorities from the FDA, industry and critical component suppliers to discuss strategies and best practices for instituting and maintaining a robust and responsible supplier control program. Visit MTLI online for more information. LinkedInFacebookTwitterEmail this Story
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Position TitleCompany NameLocation
Corporate Compliance ManagerEndologix, Inc.Irvine, CA
Sr. Clinical Research AssociateEndologix, Inc.Irvine, CA
Director of Regulatory Systems; CorporateSmith & Nephew, Inc.Andover, MA
Director of Regulatory Systems - CorporateSmith & Nephew, Inc.Memphis, TN
Director of Internal Audit QA/RA - CorporateSmith & Nephew Inc.Memphis, TN
Principal Regulatory Affairs Specialist-Endo-Santa Rosa CAMedtronicSanta Rosa, CA
Senior Business Systems Analyst - 001324Edwards LifesciencesIrvine, CA
Staff Engineer - Cardiac Surgery Systems - 001281Edwards LifesciencesIrvine, CA
Regional Sales DirectorRegenesis Biomedical, Inc.Home based office, CA
Manager, Regulatory Affairs - 1 of 2Johnson & JohnsonFremont, CA
R&D Technical Project ManagerEndologix, Inc.Irvine, CA
Post Market Surveillance Regulatory SpecialistW.L. GorePhoenix, AZ
Regulatory Affairs ProfessionalW.L. GoreFlagstaff, AZ
Director Global Marketing -- Core Brand ManagementCovidienNew Haven, CT
Regulatory Affairs ProfessionalW.L. GoreFlagstaff, AZ
Regulatory Affairs ProfessionalW.L. GoreFlagstaff, AZ
Sr. Quality Engineer - New Product DevelopmentEndologix, Inc.Irvine, CA
Regulatory Affairs Professional — Venous/AccessW.L. GoreFlagstaff, AZ
Vice President – Research, Payment and Health Care Delivery PolicyAdvaMedWashington, DC
Public Affairs CoordinatorAdvaMedWashington, DC
Director, MarketingEndologix, Inc.Irvine, CA
Senior Program Manager - Critical Care - 001311Edwards LifesciencesIrvine, CA
Project Manager, Supplier Development - Transcatheter Heart Valve - 001303Edwards LifesciencesIrvine, CA
Regulatory Affairs Manager Johnson & Johnson Irwindale, CA
Click here to view more job listings.

The word 'listen' contains the same letters as the word 'silent.' "
--Alfred Brendel,
Austrian pianist

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