• Marketing your Medical Device in the new FDA/OIG Enforcement Environment Part 1

    Tuesday, June 10, 2014 11:00am - Tuesday, June 10, 2014 1:00am
    Category: Conferences
    Organizer: DuValEDU

    Marketing a medical device today is getting increasingly complicated and requires an increasingly sophisticated knowledge-base and skill set for executives, compliance, legal, marketers, sales management, field sales, regulatory affairs and clinical affairs professionals.

  • FDA Device Clearance Process

    Wednesday, May 14, 2014 9:00am - Wednesday, May 14, 2014 9:45am
    Category: Conferences
    Organizer: BioEnterprise

    Companies seeking medical device market approval and clearance often encounter roadblocks when it comes to submissions.

  • Helping FDA Clear Your 510(k): Understanding FDA's Wants & Needs

    Thursday, April 3, 2014 7:00am - Thursday, April 3, 2014 5:00am
    Category: Conferences

    Knowing how to get your 510(k) application through FDA quickly can save millions of dollars in unnecessary time and expense. Mark DuVal, a national authority who speaks and writes frequently on the 510(k) program is in Silver Spring, Maryland at FDA two to three times a month negotiating Pre-Submission, IDE, 510(k), de novo, PMA and combination product issues, as well as planning and executing panel meetings for his clients.  He has also filed a Citizen Petition with FDA trying to influence FDA’s administration of the 510(k) program. 

  • The Physician Sunshine Act: Are You Ready to Report & React?

    Thursday, March 20, 2014 8:00am - Thursday, March 20, 2014 4:00am
    Category: Conferences

    Tracking for the Physician Payment Sunshine Act (the “Sunshine Act”) started August 1, 2013.  How is your company dealing with it?  The Sunshine Act will have a long lasting impact on the way drug and device companies market products to doctors.  Don’t underestimate the complexity of this law and the many granular and specific interpretations it requires for your organization.  Depending on company size, CMS estimates companies will have to spend tens of thousands or even hundreds of thousands each year to comply with the new law.  Those in industry know those are very conservative numbers. Although the law has many critics, it is here to stay.  Marketers and CEOs are trying to decide whether to pivot, or keep doing business the way they have always done.  The demands of the complying with the new law will be expensive and time consuming and require a level of transparency not seen before.  This seminar will help you understand the law, the current implementation interpretations and challenges and will help you prepare for a CMS audit. 

The information on our site is not intended to provide specific legal advice.

Helping clients be appropriately aggressive, yet compliant.™