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• Electronics | Packaging & Sterilization | Testing
  

  Transporting Lithium Batteries Used in Medical Devices

  What you need to know about the UN 38.3 standard.

  Online Exclusives Rick Byczek, Global Director of Transportation Technologies, Intertek 04.16.19
  

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  Improvements to Medicare’s NTAP for New, Innovative Medical Devices

  The new technology add-on payment (NTAP) program is a payment system designed by Congress to encourage the uptake of new and costly medical technologies1 in the hospital setting under the Hospital Inpatient Prospective Payment System (IPPS) in Medica…

  Jeffrey J. Kimbell and Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 04.03.19
  

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• Software & IT
  

  Safe and Secure: Ensuring the Cybersecurity of Connected Medical Devices

  The need to secure a connected medical device is critical to ensure patient safety and protect a patient’s data and personal information.

  Online Exclusives Wayne Stewart, Director, EWA Canada, an Intertek Company 01.02.19
  

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• Electronics | R&D & Design
  

  Magnetics in Medical Devices: A Practical Guide

  Sometimes magnets are behind a core device technology and the commercialization team has to account for interference.

  Online Exclusives Nigel Syrotuck, Mechanical Engineer, StarFish Medical 10.17.18
  

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• Software & IT
  

  Risk Management Approaches to Machine Learning in Medical Devices

  Insights on regulatory pathway, algorithms, cybersecurity, and validation.

  Steve Tyrrell, Regulatory Compliance Associates Inc., and Alex Reid, Proactive Cyber Security 10.16.18
  

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  Medical Devices and the Political Climate of 2018: An Update from the Swamp

  The November midterm elections have the potential to shift the power balance, leadership, and legislative agenda of Congress, which would certainly have a sizable impact on the medical device industry. In addition to what lies ahead, current actions…

  Jeffrey J. Kimbell and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 05.03.18
  

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• Electronics | R&D & Design
  

  7 Considerations for Designing Medical Device Mechanisms

  Mechanisms can be the defining feature of a successful medical device.

  Online Exclusives Nigel Syrotuck, Mechanical Engineer, StarFish Medical 02.23.18
  

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  Comparing cGMP Pharma vs. Device: Subpart A—General Provisions (Part II)

  Despite maintaining a somewhat close professional relationship, the pharmaceutical and medical device industries are complete strangers in many ways. Between product development timelines, innovation, and outsourcing, the two sides lead mostly separa…

  James A. Dunning, QPC Services LLC 07.26.17
  

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

  Insuring Medical Device Wearables Are Covered

  When developing a medical device, there are a number of considerations companies must keep in mind to ensure the success of the product. Manufacturability, sterilization, reimbursement, and clinical need are just a few of the factors reviewed during…

  Sean Fenske, Editor 06.09.16
  

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• Contract Manufacturing | Materials | Molding | R&D & Design | Testing
  

  How Do Good Laboratory Practice Regulations Apply to Medical Devices?

  Industry consultants provide a primer on the use of GLP in medtech.

  Aaron Burke, Pacific BioLabs 09.11.14
  

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