ADVAMED Association News
See AdvaMed-MTLI's schedule of courses
AdvaMed SmartBrief | Nov 21, 2008
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses here.
2009 International Medical Device Industry Compliance, Regulatory & IP Conference
AdvaMed SmartBrief | Nov 21, 2008
AdvaMed is leading a contingent of global medical device associations worldwide in organizing a 2009 International Medical Device Compliance, Regulatory and Intellectual Property Conference in Rome from May 25 to 27. The event will include top issues including compliance/ethics, regulatory and IP. Early-bird registration will be available through Jan. 14. Register now for the event and book your accommodations. Visit the event page.
Risk-Based Strategies for Design Control and Software Validation
AdvaMed SmartBrief | Nov 20, 2008
During this seminar, Jan. 21 in Orlando, Fla., you'll learn from FDA and industry leaders:
- How Ethicon-Surgery has integrated product innovation into its design processes
- How to implement a risk-based design-control process based on IEC 62304:2006
- The most common 483 observations for design control and software validation
Enhancing Safety Risk Management
AdvaMed SmartBrief | Nov 19, 2008
During this seminar on Jan. 20, 2009, in Orlando, Fla., you'll learn from FDA and industry leaders:
- Causes of safety related recalls and how they could have been prevented
- What to include in your risk analyses, risk evaluation, risk control and post-production information
- Lessons from safety recalls and how they can be prevented
Recalls from A to Z -- Regulations, Decisions, Procedures, Best Practices
AdvaMed SmartBrief | Nov 18, 2008
How should medical-technology companies responsibly manage product recalls? This conference, Nov. 19 to 20 in Bethesda, Md., provides practical guidance from regulatory and business perspectives on handling this troubling action. Key experts from FDA's Center for Devices and Office of Enforcement, together with leaders from industry, discuss FDA regulations, guidances and expectations, internal company decision-making issues, productive communications between companies and FDA, and effective recall procedures. This is the conference to help companies prepare for and manage recalls. Get more information. Medical Technology Learning Institute -- Education Beyond a Degree
Validation of Non-product Software: Assuring Compliance and Improving Quality
AdvaMed SmartBrief | Nov 18, 2008
During this seminar, Jan. 22, 2009, in Orlando, Fla., you'll learn from FDA and industry leaders:
- How to use TIR 36 to define validation practices for non-product software.
- FDA's compliance observations regarding software validation and Part 11.
- How industry leaders are using ITIL to tailor software validation processes.
Steps to eMDRs -- Current Status -- Future Direction
AdvaMed SmartBrief | Nov 17, 2008
Electronic MDRs are coming. Electronic reporting is still voluntary today but will soon become a requirement. Early planning and preparation will make the transition easier. During this one-day conference, on Nov. 18 in Bethesda, Md., key FDA speakers will discuss the current status of the eMDR program, coding issues, and plans for MedWatchPlus and FAERS -- the new unified data-entry portal and adverse event reporting system. Industry speakers from large and small companies will present actual examples of what is involved in preparing for and setting up systems for high- or low-volume reporting. Ample opportunity for questions and discussion will enable you to get the information you need to plan most effectively for the future. Get more information. Medical Technology Learning Institute -- Education Beyond a Degree
International Reimbursement, Nov. 13 to 14 -- Washington, D.C.
AdvaMed SmartBrief | Nov 12, 2008
Obtaining appropriate reimbursement for medical technology in a global market is a key part of a successful business strategy. The subject is extremely complex, however, with wide variation in the reimbursement and coverage systems of each country, as well as in related areas such as technology assessment and evidence requirements. Add to that each country's differing mix of payers, including fundamental and unique differences between private and government payers in some countries, and global reimbursement becomes one of the most challenging areas for today's med-tech businesses. In this two-day workshop, leading experts discuss the global reimbursement landscape, focusing on high-level planning and resource allocation, major regional differences, tips and pitfalls, and specific country scenarios in Europe and Asia, including examples of successful corporate strategies. Get more information. Medical Technology Learning Institute -- Education Beyond a Degree
Just announced: 2009 International Medical Device Industry Compliance, Regulatory & IP Conference
AdvaMed SmartBrief | Nov 11, 2008
AdvaMed is leading a contingent of global medical device associations worldwide in organizing a 2009 International Medical Device Compliance, Regulatory and Intellectual Property Conference in Rome from May 25 to 27. The event will include top issues including compliance/ethics, regulatory and IP. Early-bird registration will be available through Jan. 14. Register now for the event and book your accommodations. Visit the event page.
AdvaMed responds to CMS announcement on '09 physician fee schedule and gainsharing
AdvaMed SmartBrief | Nov 03, 2008
In an Oct. 31 statement, AdvaMed said it was pleased that the CMS did not progress on a proposal to launch a gainsharing program in issuing its final physician fee schedule for calendar year 2009.
The Association's statement quoting Michael A. Mussallem, chairman and CEO of Edwards Lifesciences, who is also AdvaMed's board chairman, observed that patient care could be compromised by physician incentives to use less expensive, older and outdated equipment when newer technologies would be more appropriate. CMS announced that it will seek additional public comment on the proposal before it makes a decision. Read AdvaMed's full statement.
Audio Conference: 510(k) Standards Data Report -- Form 3654
AdvaMed SmartBrief | Oct 31, 2008
The use of consensus standards in 510(k) submissions offers a less burdensome approach to satisfying certain requirements for regulatory clearance of medical devices and diagnostics. In September 2007, FDA issued a data report form intended to more efficiently capture standards data. In the experience of some companies, however, the form made the process more challenging, while other companies are uncertain about its appropriate use. In this 90-minute audio conference, Nov. 7, 1 to 2:30 p.m. EDT, the director of the CDRH Standards Management Staff, along with representatives from ODE and from industry, will discuss the intent of the form, its use by CDRH reviewers and the company perspective. Participants in the call will be invited to submit questions in advance -- as well as ask questions live -- to guarantee that all issues and concerns are appropriately addressed. Medical Technology Learning Institute -- Education Beyond a Degree
Audio Conference: Compliance Obligations and the Foreign Corrupt Practices Act, Oct. 30, 2 to 3:30 p.m. EDT
AdvaMed SmartBrief | Oct 29, 2008
The Foreign Corrupt Practices Act is an extremely important issue for medical-device manufacturers, especially in light of increased scrutiny by the U.S. Department of Justice. The recent $2 million settlement of allegations that a device company violated the FCPA by paying a foreign government to assist in obtaining business, and four settlements last year by the largest makers of artificial hips and knees involving financial relationships with consulting orthopedic surgeons, demonstrate the urgent need for device companies to address FCPA-related compliance program implications for their foreign operations. The post-settlement "real life" experiences of the companies involved in these cases has shifted FCPA compliance planning and risk management to the forefront of the device-company compliance agenda. Learn more about compliance. Medical Technology Learning Institute -- Education Beyond a Degree
Investor match company IPEEX joins AdvaMed's Business Solutions Program
AdvaMed SmartBrief | Oct 27, 2008
AdvaMed has announced an expansion of its Business Solutions program that provides smaller, emerging growth companies with access to industry-leading suppliers and professional service firms to help them succeed. With the addition of new partner IPEEX, the AdvaMed program moves into a higher level of service to help its smaller members better connect with sources of venture capital. Read AdvaMed's news release.
Join AdvaMed-MTLI for our First Diagnostics Reimbursement Seminar
AdvaMed SmartBrief | Oct 23, 2008
Navigating the diagnostics reimbursement process poses unique challenges in a dramatically changing landscape. Whether your company is large or small, whether your focus is manufactured test kits or laboratory-developed tests, good, practical information on coverage, coding and payment is hard to find. Payers are redefining the role and importance of clinical evidence and economic data. Join us Oct. 28 and 29 in Bethesda, Md., for the first-ever two-day conference, at which seasoned experts provide practical information on diagnostics reimbursement, including actual case studies and strategies that work. Obtain program and registration information now. Medical Technology Learning Institute -- Education Beyond a Degree
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