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• Testing
  

  Managing Risks for Medical Devices: A Guide to Understanding ISO 14971

  The intent of ISO 14971 is to provide a general “bird’s-eye view” approach to designing and implementing a risk management plan for medical devices.

  Helin Räägel, Ph.D., Biocompatibility Expert, Nelson Labs 10.08.19
  

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• Digital Health | Software & IT
  

  Nova Leah Achieves ISO 27001 and ISO 9001

  Cybersecurity solutions provider for medical device manufacturers was awarded certifications by the NSAI.

  Nova Leah 09.25.19
  

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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
  

  Biocoat Inc. Announces ISO 13485:2016 Certification

  Specialty manufacturer of hydrophilic biomaterial coatings for medical devices receives certification after consistently meeting regulatory requirements.

  PR Newswire 03.07.19
  

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  Presbia Achieves ISO 3485 Certification

  Renewal of the company’s CE Mark has been completed and is valid through 2022.

  Business Wire 02.25.19
  

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• Software & IT
  

  6 Best Practices for Complying with ISO 13485:2016

  At this stage, companies have less than six months to be compliant.

  Online Exclusives Jon Speer, Co-Founder and VP of QA/RA, Greenlight Guru 10.17.18
  

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• Packaging & Sterilization | Testing
  

  Five Aspects of the ISO 11737-1:2018 Updates You Need to Know

  What medical device manufacturers need to know about the recent changes to the ISO bioburden standard.

  Martell Winters, Director of Scientific Competency, and Wendy Wangsgard, Ph.D., Senior Scientist—Nelson Laboratories 07.23.18
  

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  ISO 13485:2016—Upgrading to the New Edition (Part 2)

  For the first time in 13 years, the International Organization for Standardization (ISO) has updated ISO 13485, the medical device industry’s framework for quality management systems (QMS). With an emphasis on risk management in the quality sys…

  Maria Fagan, President and Co-Founder, Regulatory and Quality Solutions LLC (R&Q) 05.03.18
  

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  ISO 13485 2016: Upgrading to the New Edition (Part 1)

  For the first time in 13 years, the International Organization for Standardization (ISO) has updated ISO 13485, the medical device industry’s framework for quality management systems (QMS). With an emphasis on risk management in the quality sys…

  Maria Fagan, President and Co-Founder, Regulatory and Quality Solutions LLC (R&Q) 04.03.18
  

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• Packaging & Sterilization | Testing
  

  Packaging Validations—Looking Beyond ISO 11607

  Most discussions on packaging validations for medical devices begin and end with ISO 11607: Packaging for Terminally Sterilized Medical Devices, and are laden with interpretations of how the two parts of this standard apply best to the unique aspects…

  Christopher Scott, Vice President, Eurofins Medical Device Testing 10.05.17
  

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