Search Results for 'testing'

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  MX3 Diagnostics Introduces the World’s First Portable Saliva-Based Hydration Testing System

  ‘Lab in the palm of your hand’ designed for professional sports teams, elite athletes, military personnel and healthcare providers.

  Business Wire 07.29.19
  

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• Packaging & Sterilization
  

  Package Testing and Validation: Interplay Between ISO 11607 Updates and MDR

  With recent updates to ISO 11607, Part 1 and Part 2, and the Medical Device Regulation (MDR) on track to replace Europe’s current Medical Device Directive (MDD) in 2020, medical device manufacturers are working hard to ensure their package desi…

  Britt Jones, Manager of Package Testing Services, WuXi AppTec 06.13.19
  

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• Diagnostics
  

  FDA Clears Roche to Expand Testing Menu on cobas 6800/8800 Systems for STDs

  Addition of the cobas TV/MG test to the testing menu provides the flexibility to process up to four sexually transmitted infections from one patient sample.

  PR Newswire 05.24.19
  

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• R&D & Design | Software & IT | Testing
  

  Transformative Testing: Addressing Patient Safety and Cybersecurity

  With changing regulatory landscapes and requirements, testing providers are being asked to do more in terms of ensuring the safety of medical devices.

  Mark Crawford, Contributing Writer 03.07.19
  

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  Empirical - A Family of Companies (Empirical Testing Corp., Empirical Consulting LLC, Empirical Machine LLC)

  The Empirical family of companies provides a comprehensive solution for medical device testing, manufacturing, RA/QA consulting and validation services. Empirical is your partner to successfully gain and maintain regulatory clearance or approval. We…

  Chanda Chatham, Marketing and Communications Manager 12.03.18
  

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• Cardiovascular | Neurological | Surgical | Testing
  

  Active Implantable Medical Device Testing: What You Need to Know

  Both the implanted product and non-implantable supporting equipment require testing and evaluation to specific standards.

  Online Exclusives William Stearns, Associate Senior Engineer, Intertek 08.13.18
  

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• Testing
  

  The Value of (Outside) Evaluation: Outsourcing Testing Services

  Testing service and equipment providers are challenged to stay abreast of regulatory guidelines.

  Sam Brusco, Associate Editor 03.15.18
  

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• Testing
  

  Testing…Testing…Is This Thing On? Should You Outsource Device Testing or Keep it In-House?

  When people ask me what I do, I often reply, “I break things for a living.” Yes, I say it with tongue firmly in cheek. That’s a gross oversimplification of a business I’ve been in for almost 20 years: mechanical testing for…

  Dawn A. Lissy, President & Founder, Empirical 03.07.17
  

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• R&D & Design | Testing
  

  5 Considerations for Human Factors Testing

  When developing a device, the way it will be used, who uses it, and where it’s used are all critical factors to consider.

  Online Exclusives Kady Harper, Technical Writer 09.13.16
  

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• Packaging & Sterilization | Testing
  

  Functionality vs. Simulated-Use Testing in Device Reprocessing

  A brief look at functionality vs. simulated-use testing for processing and reprocessing of reusable scopes and medical devices.

  Online Exclusives Emily Mitzel, Alpa Patel & Nick Workman, Nelson Laboratories, Contributing Columnists 09.11.14
  

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