ADVAMED Association News


Helping medical technology professionals keep pace with regulatory and compliance issues

AdvaMed SmartBrief | Jan 30, 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.


See AdvaMed-MTLI's schedule of courses

AdvaMed SmartBrief | Jan 30, 2015

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


IDE Submissions Workshop

AdvaMed SmartBrief | Jan 29, 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 | Jan 29, 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.


PMA Submissions Workshop

AdvaMed SmartBrief | Jan 28, 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.


Follow AdvaMed on Google+

AdvaMed SmartBrief | Jan 27, 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+.


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

AdvaMed SmartBrief | Jan 26, 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.




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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