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  • The Economics of a Sound Regulatory Strategy

    The Economics of a Sound Regulatory Strategy

    While it might be tempting to put off regulatory requirements on a new project, a regulatory assessment should be performed fairly early.
    Christine Scifert and Dawn Norman, M.S., MRC-X LLC 04.01.20

  • Software & IT
    Five Strategies to Navigate Regulatory Challenges in Medical Device Development

    Five Strategies to Navigate Regulatory Challenges in Medical Device Development

    Medical device products are rapidly evolving to become more personalized and connected, leveraging artificial intelligence (AI), robotics, and mobile technology. Against this backdrop of continual innovation, medical device manufacturers face uniq…
    Seth J. Goldenberg, Ph.D., Vice President, Vault Medical Device & Diagnostics, Veeva Systems 07.30.19

  • 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

  • Software & IT
    How an Automated QMS Helps to Keep Up with  Regulatory Changes

    How an Automated QMS Helps to Keep Up with Regulatory Changes

    Medical device regulations are changing rapidly, and companies have limited time to comply. The deadline for ISO 13485:2016 is March 1, 2019, so organizations have just over a year to comply. Up until February 2018, organizations were able to be a…
    Alexa Sussman, Content Marketing Writer, EtQ 03.15.18

  • Mike on Medtech: Quality vs. Regulatory

    Mike on Medtech: Quality vs. Regulatory

    Mike Drues and Sean Fenske discuss these interrelated terms and their relevance to the industry, while offering examples.
    Sean Fenske, Editor-in-Chief 03.02.18

  • 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