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  • MCRA Hires Vice President of Cardiovascular Regulatory Affairs

    MCRA Hires Vice President of Cardiovascular Regulatory Affairs

    Latest leadership team addition worked as an Interventional Cardiology Devices Branch chief at the FDA.
    PR Newswire 04.17.19

  • Software & IT
    Hand-in-Hand with Quality and (Regulatory) Changes

    Hand-in-Hand with Quality and (Regulatory) Changes

    Greenlight Guru’s founder speaks with MPO about the firm’s FDA-connected initiatives and the changing regulatory landscape.
    Online Exclusives Sean Fenske, Editor-in-Chief 04.03.19

  • The Impact of Change on Regulatory Compliance

    The Impact of Change on Regulatory Compliance

    It’s that time of year again. Time for a calendar change. Out with the old and in with the new. Time for another 12-month journey into the unknown. It’s also time for new beginnings—a period that can be simultaneously fun, exh…
    James A. Dunning, Principal, QPC Services LLC 01.30.19

  • The Regulatory Outlook for 2019

    The Regulatory Outlook for 2019

    Time seems to have passed more quickly for me this year than at any other period in my life. I’m still not sure why, but one contributing factor could be the volume and gravity of regulatory changes that have been looming on the horizon. This i…
    James A. Dunning, Principal, QPC Services LLC 11.26.18

  • Professional Development for the Quality/Regulatory Professional

    Professional Development for the Quality/Regulatory Professional

    Recently, someone asked me if colleges offer degrees in quality. I replied that many schools do indeed offer undergraduate programs in quality management or other quality focus areas, but such diplomas are rare among quality or regulatory professiona…
    James A. Dunning, Principal, QPC Services LLC 10.16.18

  • Selling Regulatory Compliance

    Selling Regulatory Compliance

    Does the title of this column strike a nerve? Does it seem crass or disrespectful to combine “selling” with “regulatory compliance”? I ask these rhetorical questions because I have found that many regulatory professionals feel…
    James A. Dunning, Principal, QPC Services LLC 07.26.18

  • Digital Health
    Mobile Medical Applications: The Regulatory Framework in the U.S. and the EU

    Mobile Medical Applications: The Regulatory Framework in the U.S. and the EU

    The medical device market is one of the largest industries in the healthcare sector, which has seen significant growth in the last 15 years. Harnessing the benefits of the digital revolution and medical technology, the industry is in a state of conti…
    Sudeep Kolluri, Solutioning Lead, Freyr 06.04.18

  • Will Regulatory Transitions Cause Some to Change Course?

    Will Regulatory Transitions Cause Some to Change Course?

    Now, perhaps more than ever before, there are significant changes occurring to the worldwide regulatory landscape, all within a relatively small window. This includes FDA, the EU’s MDR, Asia (see the article in this issue on India’s new r…
    Sean Fenske, Editor-in-Chief 04.03.18

  • Four Takeaways from Recent Regulatory Audit Changes

    Four Takeaways from Recent Regulatory Audit Changes

    From medical device production to pharmaceutical manufacturing, the life sciences demand highly regulated operations. In a perfect world, these products would be without defect every time, but the reality is processes can stray from compliance and ca…
    Alexa Sussman, Content Marketing Writer, EtQ 05.01.17

  • Cardiovascular | Contract Manufacturing | R&D & Design | Testing
    The New Role of Regulatory Affairs in Medical Device Manufacturing

    The New Role of Regulatory Affairs in Medical Device Manufacturing

    Today’s market realities have reshaped the role of regulatory affairs within the medical device development process. But are companies keeping pace?
    Kellen Hills, Contributing Writer 11.13.14