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• Software & IT
  

  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
  

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  Medical Device Legislative and Regulatory Policy: A Spring Update

  As the temperature begins to rise here in Washington, D.C., Congress continues to focus its heat on healthcare as a top priority. Looking closely at prices, lawmakers from both sides of the aisle are determined to achieve solutions to lower healthcar…

  Jeffrey J. Kimbell, David C. Rudloff, and Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 06.13.19
  

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• Software & IT
  

  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
  

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  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
  

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• Digital Health
  

  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
  

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  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
  

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  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
  

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  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
  

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• Cardiovascular | Contract Manufacturing | R&D & Design | Testing
  

  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
  

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• Contract Manufacturing | Materials | R&D & Design | Software & IT

  Continuing to Innovate in a Changing Regulatory Landscape

  Continuing to Innovate in a Changing Regulatory Landscape The medical device industry has been making headline news recently as the U.S. Food and Drug Administration (FDA) re-examines its regulation and oversight for medical device manufacturers. Re…

  Tim Mohn 07.26.10
  

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