ADVAMED Association News

3D Medical Technology: Understanding the Legal and Regulatory Challenges, Opportunities and Strategies

AdvaMed SmartBrief | Sep 27, 2016

Oct. 25 | Silicon Valley
Join us for a half-day event in Silicon Valley where we'll be discussing 3D technology and its impact across the medical device industry. We'll be joined by experts from industry and Kaye Scholer and will discuss where the technology is today, where it looks to be going, and how it will transform the industry. We'll also cover the full range of new legal issues associated with and raised by this technology. Learn more.

FDA Submissions Strategy Workshop

AdvaMed SmartBrief | Sep 27, 2016

Oct. 26-27 | Washington, D.C.
Effective navigation of the FDA application process requires an approach that is both thoughtful and strategic. This workshop is designed to prepare you for the development and execution of effective submission strategies for your Investigation Device Exemptions (IDEs), Premarket Approvals (PMAs), Humanitarian Device Exemptions (HDEs) and Premarket Notifications (510(k)s). Learn more.

510(K) Submissions Workshop

AdvaMed SmartBrief | Sep 26, 2016

Oct. 31-Nov. 1 | Washington, D.C.
FDA (invited) and industry experts are coming together to teach you the basics of 510(k) submissions. You'll learn the FDA's updates to the 510(k) process, considerations for determining a product's regulatory route to market, factors to consider when planning and assembling a 510(k) submission, and tips and hints on interacting with the FDA during the 510(k) review process. Learn more.

IDE Submissions Workshop

AdvaMed SmartBrief | Sep 26, 2016

Nov. 2 | Washington, D.C.
During this interactive workshop, FDA staff (invited) and industry experts will lead you through the regulatory and practical guidelines governing when an investigational device exemption (IDE) is required. You'll learn how to make the best use of pre-submission meetings, components of a successful IDE submission, common errors and deficiencies in an IDE application, and more. Learn more.

Reimbursement 201: A Deeper Dive into the Reimbursement Landscape

AdvaMed SmartBrief | Sep 23, 2016

Sept. 28-29 | Washington, D.C.
This next-level reimbursement workshop was created with the more advanced professional in mind. You'll walk away from this workshop with more insight into the complex and critical nature of coverage issues and policy. Learn more.

Reimbursement 101: A Primer on Medical Device Reimbursement

AdvaMed SmartBrief | Sep 23, 2016

Sept. 27-28 | Washington, D.C.
During this workshop, you will be provided with the road map and practical applications to successfully navigate the many potential reimbursement pitfalls. After an overview of current reimbursement issues, you'll hear from industry veterans and reimbursement professionals who will discuss case studies and real-life scenarios. Learn more.

PMA Submissions Workshop

AdvaMed SmartBrief | Sep 22, 2016

Nov. 3-4 | Washington, D.C.
Completing the MTLI set of interactive submissions workshops, senior industry experts and FDA staff (invited) will lead you through the strategic considerations and practical steps of filing a premarket approval. You'll learn tips for developing your submission strategy, best practices to help prepare for an inspection and more. Learn more.

Cybersecurity Summit

AdvaMed SmartBrief | Sep 21, 2016

Nov. 29 | Washington, D.C.
Bringing together the FDA and experts from across the health care industry, this summit will provide you with an in-depth and timely look at the state of medical device cybersecurity. Over the course of this one-day event, you'll participate in a mock breach and have the opportunity to observe how seasoned experts handle the issue. You'll walk away with a better understanding of how industry leaders work to secure their devices and manage cybersecurity risks, as well as the legal, public relations and other impacts of a cybersecurity incident. Learn more.

West Coast Diagnostics Summit

AdvaMed SmartBrief | Sep 21, 2016

Nov. 10 | San Diego, Calif.
The nation's leading diagnostic industry associations -- the American Clinical Laboratory Association (ACLA) and AdvaMedDx -- have teamed up to sponsor a first-of-its-kind diagnostic summit this fall in San Diego. This one-day summit will feature leaders from both the clinical laboratory and diagnostic manufacturer sectors, from government and commercial payers, from the investor community, from Congress and others. Learn more.

7th Annual Advertising and Promotion of Medical Devices Conference

AdvaMed SmartBrief | Sep 19, 2016

Nov. 10-11 | Washington, D.C.
From products to consumers to regulation and new media -- we're gathering industry practitioners to take a deep dive on the opportunities and challenges of product advertising. This annual conference will teach you how to communicate your value without overstepping legal and regulatory boundaries. FDA staff (invited), medical technology company leaders, legal experts and public affairs professionals will lead discussions. Learn more.

MedTech Compliance 101: Boot Camp

AdvaMed SmartBrief | Sep 15, 2016

Sept. 19-20 | AdvaMed office, Washington, D.C.
Whether you have recently taken on compliance responsibilities, are about to set up a new compliance structure or revamp your existing program, or simply need a refresh, this course will provide you with a thorough understanding of the compliance framework and practical approaches for addressing challenges and effectively managing compliance in a medical device company. This 1.5-day program offers individuals from start-ups to multi-billion dollar companies an intense review of the fundamentals of compliance for medical device companies. Learn more.

MedTech Compliance 201: A Deeper Dive into the Compliance Landscape

AdvaMed SmartBrief | Sep 15, 2016

Sept. 21 | AdvaMed office, Washington, D.C.
Those who manage health care compliance in medical device companies know that their work involves many complexities and that absolute issue resolutions can be elusive. This advanced one-day program will tackle some of the thornier pressing problems confronting compliance departments across the industry. During each in-depth interactive session, a single topic will receive a thorough analysis of the associated problems and approaches to manage the predictable risks and unintended consequences. Learn more.

Wearable Devices Webinar: Regulatory and Litigation Risks

AdvaMed SmartBrief | Sep 14, 2016

Sept. 15 | Virtual 1:00 p.m.-2:00 p.m. Eastern
Recent years have seen enormous growth in wearable technology products that often blur the lines between medical and consumer technology. Some uncertainty about where to draw that line remains, but the FDA has generally encouraged this growth with a "hands off" enforcement policy. Now, private litigants may be stepping in where the FDA hasn't dared to tread, claiming these products can cause harm when not held to rigorous standards of accuracy required for medical products. This webinar will explore the lay of the land for FDA oversight of wearable products, recent developments in product liability litigation, and what the future may hold for this burgeoning area. Learn more.

10th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference

AdvaMed SmartBrief | Sep 08, 2016

April 26-27, 2017 | Washington, D.C.
This annual conference brings together leading authorities from the FDA, industry and academia to address statistical topics through two tracks: therapeutic device and diagnostics. More details to be announced in the fall of 2016.

Medical Device Complaints, MDRs & Reports Workshop

AdvaMed SmartBrief | Sep 01, 2016

Oct. 5-6 | South San Francisco, Calif.
How do you 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? Industry experts and FDA staff (invited) will explore these issues during this day-and-a-half workshop. Learn more.

Sign up for AdvaMed SmartBrief

Designed specifically for manufacturers of medical devices, health care information systems and diagnostic products, AdvaMed SmartBrief is a FREE e-mail newsletter. By providing a summary of the day's most important medical technologies news, AdvaMed SmartBrief saves you time and keeps you smart. Learn more