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  Globalization: Will Your 2019 Regulatory Strategy Help You Win in 2020?

  Successful medtech leaders have ongoing regulatory strategies for their respective businesses.

  Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 09.06.19
  

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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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• Contract Manufacturing
  

  Turning a Regulatory Headache into a Competitive Advantage

  Understanding 21 CFR Part 11 and EU Annex 11 compliance.

  Online Exclusives David Kralovetz, Cincinnati Test Systems 07.23.19
  

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  TransEnterix Announces Japanese Regulatory Approval of the Senhance Surgical System

  Regulators approved the product for use in laparoscopy for general surgery, gynecology, urology and certain thoracic procedures.

  Business Wire 07.17.19
  

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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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  Premier Research Names New Medical Device Research and Regulatory Process Experts

  Company hires three medical device and diagnostics specialists.

  Premier Research 04.19.19
  

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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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• 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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