ADVAMED Association News
Medical Device Complaints, MDRs & Reports Workshop
AdvaMed SmartBrief | Jan 18, 2017
May 23-24 | Washington, D.C.
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 will explore these issues during this two-day workshop. Learn more.
Start saving with the AdvaMed Purchasing Group
AdvaMed SmartBrief | Jan 18, 2017
The AdvaMed Purchasing Group is a new member-only benefit that helps companies purchase the very best goods and services from nationally recognized suppliers at the very best cost, using a trusted and proven vetting system and the collective purchasing power of our membership. Participation is free for AdvaMed members, and there are no minimum commitments. Get started today.
AdvaMed 2017 Payment Policy Conference
AdvaMed SmartBrief | Jan 17, 2017
May 16-17 | Baltimore, Md.
As the reimbursement and coverage landscapes for the medical technology industry are continuously changing, AdvaMed's 3rd Annual Payment Policy Conference will convene device manufacturers, hospitals, insurers, the CMS and Capitol Hill for in-depth discussion and analysis of these key issues. The need for a medical device to demonstrate how it improves efficiency and quality of care is only increasing as the industry moves toward alternative payment models in this changing payer world. Join us for a day and a half of learning, insights and networking.
10th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
AdvaMed SmartBrief | Jan 16, 2017
April 26-27 | Washington, D.C.
Join us to celebrate our 10th year of the Annual FDA-AdvaMed Medical Devices and Diagnostics Statistics Conference. This annual conference brings together leading authorities from the FDA, industry and academia to address statistical topics through two tracks -- therapeutic device and diagnostics. Learn more.
Recalls from A to Z: Regulations, Decisions, Procedures, and Best Practices
AdvaMed SmartBrief | Jan 13, 2017
March 29-30 | Washington, D.C.
During this workshop you'll establish a clear understanding of how the regulatory affairs function is pivotal to every recall and every team decision. After partaking in detailed discussions and strategies of communicating with the FDA, you'll learn to understand the points to consider when writing public recall notifications. At this interactive workshop, you will have access to network with industry leaders and FDA experts. Learn more.
The Digital MedTech Conference
AdvaMed SmartBrief | Jan 12, 2017
March 2 | San Francisco, Calif.
Bringing together leading experts and innovators from across the industry, this one-day event will also provide unparalleled access to key decision-makers. Anchored by its timely and robust programming, panels will offer unmatched content to guide digital health decisions. Attendees will obtain sophisticated and actionable insights into the critical technology and business issues facing the development and deployment of digital health devices, tools and services. In its inaugural year, the conference will offer insights into the current and future challenges, opportunities and trends in the digital health space. Learn more.
PMA Submissions Workshop
AdvaMed SmartBrief | Jan 11, 2017
March 2-3 | Irvine, Calif.
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.
IDE Submissions Workshop
AdvaMed SmartBrief | Jan 10, 2017
March 1 | Irvine, Calif.
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.
510(k) Submissions Workshop
AdvaMed SmartBrief | Jan 09, 2017
Feb. 27-28 | Irvine, Calif.
The 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 FDA during the 510(k) review process. Learn more.
2017 Latin America Compliance Conference
AdvaMed SmartBrief | Jan 05, 2017
Feb. 21-22, 2017 | Bogota, Colombia
Developed by industry and association leaders for the medical device industry and based on the latest and emerging trends in global medical technology compliance, the 2017 Latin America Compliance Conference is the most comprehensive medical technology meeting for device industry executives, specialty device industry lawyers, compliance professionals, international policymakers and other industry stakeholders focused on Latin American compliance issues. The conference will bring together device industry regulators, compliance professionals, legal counsel, senior executives and industry observers to analyze the major compliance challenges of the day and to discuss approaches to practical and effective management and compliance across the region. Learn more.