• Mobile Medical Apps Webinar

    • On: February 17, 2015 at 11:02AM
    • Category: Conferences

    How does FDA regulate mobile medical applications? What should companies consider when designing and promoting mobile medical apps?  This program will discuss FDA’s Mobile Medical Applications final guidance.  Topics include the FDA’s regulatory oversight of mobile medical apps, e.g., software used on smart phones, tablets and other devices.  This session will discuss the latest updates from FDA relating to mobile Medical apps.

  • Medical Device and Diagnostic Regulatory Breakout

    • On: January 26, 2015 at 01:01AM
    • Category: Conferences

    The Food and Drug Administration has openly commented on its objective to become more of a proponent and less of an obstacle for innovative pharmaceuticals and medical devices to enter the marketplace. However, the life science industry still views the regulatory approval process as a difficult path to navigate due to stringent requirements for clinical data, lengthy approval timelines and a lack of transparency from the FDA. To improve the relationship between manufacturers and the agency, a collaborative environment must be fostered through effective communication and an understanding of FDA's plans for transforming regulatory pathways into a catalyst for medical innovation.

  • The Pre-Submission Meeting: Friend or Foe?

    • On: November 5, 2014 at 09:11AM
    • Category: Conferences

    Device manufacturers, biodesign innovators, regulatory specialists, and academics register now for the 3rd Annual UGA Medical Device Regulations Conference! This conference, cosponsored by the US FDA and the University of Georgia’s Office of BioPharma Regulatory Affairs, will provide educational and networking opportunities to help shape the future of medical device advancement from a regulatory science perspective.

  • Encouraging Communications & Transparency Between Industry and Regulators

    • On: November 4, 2014 at 08:11AM
    • Category: Conferences

    Effective communication with regulatory agencies throughout the clearance and approval process of a medical device continues to be a core challenge for regulatory affairs executives.

The information on our site is not intended to provide specific legal advice.
Helping clients be appropriately aggressive, yet compliant. TM