ADVAMED Association News


Medical Device Complaints, MDRs and Reports

AdvaMed SmartBrief | Mar 04, 2015

March 18-19
Arlington, Va.
FDA staff (invited) and experts are coming together to discuss setting up a complaint system, handling complaints and trending, measuring the effectiveness of our complaint system and more. Past topics include setting up a complaint system, trending and measuring effectiveness of your system, understanding MDRs and more. Learn more.


Helping medical technology professionals keep pace with regulatory and compliance issues

AdvaMed SmartBrief | Mar 04, 2015

AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for Medical Technology Professionals. The ARCC Program is a relevant and timely collaboration between AdvaMed and UL EduNeering that helps medical technology professionals to expand their knowledge of quality, regulatory and compliance topics. Learn more.


Molecular Diagnostics and the Changing Landscape

AdvaMed SmartBrief | Mar 03, 2015

March 12-13
Washington, D.C.

The regulation of molecular diagnostics, testing and tools in the field, and today's challenges for diagnostics are a few of the topics that will be discussed during this two-day interactive workshop. Past topics include OIR outlooks, the legislative landscape, regulations of biomarkers, submissions, biobanking and more. Learn more.


Follow AdvaMed on Google+

AdvaMed SmartBrief | Mar 03, 2015

Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting innovation, access and the bottom line. Network with industry experts and leaders. Our Google+ page is interactive and incorporates updates from key stakeholders, influencers and industry thought leaders as well as regulatory and policy experts from the FDA and CMS. Follow us on Google+.


8th Annual FDA/MTLI Medical Device and IVD Statistical Issues Workshop

AdvaMed SmartBrief | Mar 02, 2015

April 29-30
Westin Crystal City, Arlington, Va.
This annual workshop, co-sponsored by the FDA and AdvaMed, brings together leading authorities from the FDA, industry and academia to address statistical topics in both therapeutic device and diagnostics tracks. Topics in the past have included missing data in studies of medical devices and diagnostics, adaptive designs in device trials, design and analysis of clinical trials with recurrent event endpoints, limit of detection methodologies, traceability and uncertainty of measurement, novel clinical trial design, clustered data and more. Learn more.


Short Course on Adaptive Design

AdvaMed SmartBrief | Mar 02, 2015

April 28
Westin Crystal City, Arlington, Va.

Preceding our 8th Annual Statistical Issues Workshop, the American Statistical Association is co-sponsoring a short course on Adaptive Design. The course will be taught by Dr. Christopher Coffey, University of Iowa. Learn more.


Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!

AdvaMed SmartBrief | Feb 27, 2015

Build close relationships with member companies, both small and large, and receive an intimate understanding of the key issues affecting innovation, access and the bottom line. Interact in discussions that leverage the leadership and expertise of the medical technology industry. This social group is full of key stakeholders, influencers and industry thought leaders as well as regulatory and policy experts from the FDA and CMS. Aside from practical learning opportunities, this LinkedIn group provides the premier opportunity to network with key players from virtually every aspect of the industry. Link to the AdvaMed MTLI LinkedIn group page.  Link to the AdvaMed MTLI Twitter account.


See AdvaMed-MTLI's schedule of courses

AdvaMed SmartBrief | Feb 25, 2015

Continue your professional development! See AdvaMed-MTLI's schedule of courses.


PMA Submissions Workshop

AdvaMed SmartBrief | Feb 25, 2015

Thursday, Feb. 26, to Friday, Feb. 27
Loews Madison Hotel, Washington, D.C.
Senior industry experts and members of the CDRH device evaluation and bioresearch monitoring staff (invited) will lead professionals through the strategic considerations and practical steps of filing a Premarket Approval. Topics to be discussed include the preparation needed for an adviser panel meeting, tips to prepare for an inspection, how to deal with unexpected clinical outcomes and more. Learn more.


IDE Submissions Workshop

AdvaMed SmartBrief | Feb 24, 2015

Wednesday, Feb. 25
Loews Madison Hotel, Washington, D.C.
During this interactive workshop, FDA staff leaders (invited) and industry experts will lead professionals through the regulatory and practical guidelines governing when an investigational device exemption (IDE) is required. Topics to be discussed include the components of a successful submission, common errors, the ins and outs of BIMO inspections and more. Learn more.


510(k) Submissions Workshop

AdvaMed SmartBrief | Feb 19, 2015

Monday, Feb. 23, to Tuesday, Feb. 24
Loews Madison Hotel, Washington, D.C.
Industry experts and key personnel from the FDA CDRH 510(k) staff (invited) are coming together to discuss 510(k) submissions. Topics to be discussed include FDA updates to the 510(k) process, factors to consider when assembling a submission and more. Learn more.




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