ADVAMED Association News

Investigational Device Exemption Submission workshop

AdvaMed SmartBrief | Jan 05, 2009

MTLI offers this one-day interactive workshop on Feb. 25, 2009, in Las Vegas, to lead attendees through the regulatory and practical guidelines governing when an IDE is required, how to compile an effective IDE application, the rules governing clinical studies and human subject protection, Institutional Review Boards, types of pre-IDE meetings and communications, early/expanded access, foreign studies and export, and reimbursement for investigational devices. Register now. Medical Technology Learning Institute -- Education Beyond a Degree

510(k) Submissions -- The Course for Beginning RA Professionals for Preparing a 510(k)

AdvaMed SmartBrief | Jan 05, 2009

This interactive workshop, Feb. 23 to 24, 2009, in Las Vegas, 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 FDA during the review process and dealing with post-clearance issues. Register now for this course. Medical Technology Learning Institute -- Education Beyond a Degree

FDA Inspections: What to Expect & What to Do -- Jan. 22, 2009, Orlando, Fla.

AdvaMed SmartBrief | Jan 02, 2009

Every medical technology company will go through FDA inspections. Knowing what to expect, what FDA expects, common pitfalls, how to prepare employees and handle your response will help minimize the risks and improve the outcome of this unavoidable, sometimes challenging, experience. A leading regulatory attorney, industry experts and FDA investigators teach you the regulatory authority, typical procedures and best practices for managing an inspection. Register now. Medical Technology Learning Institute -- Education Beyond a Degree

Medical Technology Reimbursement Specialist workshop

AdvaMed SmartBrief | Jan 02, 2009

Join us for this intensive program, Feb. 17 to 20, 2009, in Las Vegas, where leading experts in the field lead participants through didactic sessions, case studies and working hypothetical exercises. This comprehensive workshop is designed for beginning and seasoned reimbursement professionals, as well as sales and marketing, product managing, strategic planning and all others who might benefit from a working understanding of reimbursement and its relationship to company business objectives and product strategies. Register for this event. Medical Technology Learning Institute -- Education Beyond a Degree

Validation of Non-product Software: Assuring Compliance and Improving Quality

AdvaMed SmartBrief | Dec 31, 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.

You'll also get custom checklists for Part 11 and TIR 36 as well as a sample software validation procedure. Get more information. Medical Technology Learning Institute -- Education Beyond a Degree

Complaints, MDRs, Reports of Removals and Corrections, and Recalls

AdvaMed SmartBrief | Dec 31, 2008

How do med-tech companies implement and measure the effectiveness of a complaint-handling system covering a diverse set of possible products and problems? How are complaint files managed across multiple domestic and international facilities? When do complaints rise to the level of MDRs, and how do you handle recalls? What are the current FDA enforcement trends in these areas? Through didactic sessions, interactive exercises and discussion of pre-submitted questions, expert industry faculty and FDA speakers will explore these issues in practical terms Jan. 20 and 21, 2009, in Orlando, Fla. Register now. Medical Technology Learning Institute -- Education Beyond a Degree

Risk-Based Strategies for Design Control and Software Validation

AdvaMed SmartBrief | Dec 30, 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

You'll also get guidelines and checklists for code, design description, requirements specification and test review. Get more information. Medical Technology Learning Institute -- Education Beyond a Degree

Enhancing Safety Risk Management

AdvaMed SmartBrief | Dec 30, 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

You'll also get a checklist with more than 130 common safety risk mitigation techniques commonly used to reduce risk. Get more information. Medical Technology Learning Institute -- Education Beyond a Degree

Massachusetts Code of Medical Device Manufacturer Conduct

AdvaMed SmartBrief | Dec 29, 2008

Massachusetts is preparing regulations to implement a first-of-its-kind drug and medical-device marketing law requiring firms to abide by a state-developed code of conduct and to report payments to health care providers. Every device firm needs to understand the implications of this law, which will significantly affect activities in Massachusetts and may be copied in other states and at the federal level. Join us Jan. 7, 2009, from 2 to 3:30 p.m. EST as experts intimately familiar with the Massachusetts law and evolving thoughts on its implementation and company best practices share their knowledge and experience. Learn what will and will not be permitted under the law, the implementation timetable and the status of marketing restrictions in other states and at the federal level. Register now. Medical Technology Learning Institute -- Education Beyond a Degree

2009 International Medical Device Industry Compliance, Regulatory & IP Conference

AdvaMed SmartBrief | Dec 29, 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.

PMA Submissions Workshop

AdvaMed SmartBrief | Dec 26, 2008

Completing the MTLI set of interactive submissions workshops, Feb. 26 and 27 in Las Vegas, senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staffs lead participants through the strategic considerations and practical steps of filing a PMA, illustrated with real-world case studies. Topics include strategy development and evidence requirements, productive meetings with FDA, the mechanics of submission development, advisory panels, inspectional activity, conditions of approval studies and the care and feeding of approved PMAs. Sign up for the workshop. Medical Technology Learning Institute -- Education Beyond a Degree

AdvaMed applauds improvement of the Innovation Clause; effort should speed patient access to innovative technologies in Germany

AdvaMed SmartBrief | Dec 23, 2008

Stephen J. Ubl, AdvaMed president and CEO, issued the following statement Dec. 19 regarding the German government's passage of the Hospital Financing Reform Act and improvements to the Innovation Clause.

"This important amendment to the Innovation Clause (section 6 of the Hospital Reimbursement Act) will now allow hospitals the right to request reimbursement for innovative technologies in an expedited manner."

Read AdvaMed's complete announcement.

AdvaMed's compliance leadership expands with updated Code of Ethics

AdvaMed SmartBrief | Dec 19, 2008

AdvaMed announced Thursday that its board of directors has unanimously approved a major update of its Code of Ethics on Interactions with Health Care Professionals. Read the complete release.

AdvaMed applauds Japanese government program on medical-device approval

AdvaMed SmartBrief | Dec 18, 2008

AdvaMed issued a statement Dec. 17 announcing its support for steps taken by the Japanese government to speed the availability of innovative medical technologies to patients by creating a more efficient and predictable medical device review process.

The five-year Action Program will triple the number of medical-device reviewers in Japan by 2013. Additionally, Japan developed stringent performance goals to substantially improve review times in exchange for higher industry user fees.

Read AdvaMed's news release.

Webinar -- Electively Accelerating Product Development: Proven Techniques to Reduce Time-to-Market

AdvaMed SmartBrief | Dec 10, 2008

In this Dec. 11 webinar, AdvaMed Associate member MPR will discuss proven techniques that will decrease your company's costs and help you avoid common pitfalls in the product development cycle. These techniques have been applied to both small and large manufacturers. Register now. AdvaMed Emerging Growth Company Council: Our only agenda ... advancing yours.

See AdvaMed-MTLI's schedule of courses

AdvaMed SmartBrief | Dec 08, 2008

Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses here.

Gender Differences in Cardiovascular Device Trials

AdvaMed SmartBrief | Dec 08, 2008

FDA's Center for Devices and Radiological Health plans to publish a Level 1 draft Guidance Document on the study and analysis of sex/gender differences in cardiovascular medical-device trials reviewed by FDA. This workshop, Dec. 9 in Silver Spring, Md., will explore issues surrounding the inclusion of women in cardiovascular device trials, including historical perspectives, regulatory requirements and considerations, treatment biases and recruitment challenges. At this workshop, FDA will also present recommendations for the guidance document and rationales behind them. Get more information. Medical Technology Learning Institute -- Education Beyond a Degree

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