• 510(k) An Industry Perspective

    Wednesday, October 30, 2013 11:00am - Thursday, October 31, 2013 5:00pm
    Category: Conferences
    Organizer: Medcon 2013

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  • Moving in the Right Direction: Regulatory Progress in Device Clearance & Approval

    Monday, October 28, 2013 8:00am - Monday, October 28, 2013 8:45am
    Category: Conferences
    Organizer: Q1 Productions

    Keynote speaker and panel moderator.

    Moving in the Right Direction: Regulatory Progress in Device Clearance & Approval

  • Regulatory Pains

    Wednesday, October 16, 2013 8:30am - Wednesday, October 16, 2013 9:30am
    Category: Conferences

    The MichBio Expo is the largest gathering of bioscience professoinal in Michigan, and MichBio as the industry trade association, endeavors to bring the most timely topics and experts to insure a top-notch program. This year, the theme is 'Bio-Growth through Bio-Innovation', and our Keynote Speaker will be Stelios Papodopoulos, PhD. Chairman of Exelixis. In additiong, the event will feature a Bio-Industry Town Hall, CEOs Unplugged session, multiple track sessions, facility tours, and a Biosciences Emerging Showcase for start-ups seeking investment.

  • 510(k) Delays: Is it FDA or Quality?

    Thursday, May 2, 2013 12:45pm - Thursday, May 2, 2013 1:45am
    Category: Conferences

    MedCon 2013, Xavier University, Cincinatti, OH.

    Industry has ongoing concerns that the 510(k) review process continues to delay approvals and stifle innovation. This session will discuss FDA's recently released refusal to file guidance and common quality issues with 510(k) submissions. The discussion will include FDA performance metrics under the current regulations and changes implemented with MDUFMA III. An industry perspective will be presented using representative case studies.

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

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