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• Materials
  

  Peak Obtains ISO 13485:2016 and 9001:2015 Certifications

  Offers toll processing and custom formulations for the medical and industrial markets.

  Peak Performance Compounding Inc. 08.04.20
  

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• Software & IT
  

  Six Mistakes to Avoid When Implementing ISO 13485

  Ditching the checkbox mentality and last-minute scrambles.

  Online Exclusives Jon Speer, founder and VP of QA/RA at Greenlight Guru 01.20.20
  

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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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  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 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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  Compounding Solutions Receives ISO 13485:2003 Quality Certification

  The company had previously been certified to the ISO 9001:2008 standard.

  Compounding Solutions 12.20.16
  

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• Contract Manufacturing | R&D & Design | Testing
  

  ISO 13485:2016—Are Your Suppliers Ready?

  The ISO Standard has been released and manufacturers need to ensure their supplier quality-related procedures are compliant.

  James Shore, Director of Quality, Titan Medical Inc. and John Freije, Principal Consultant and Owner, Freije Quality Engineering LLC 10.12.16
  

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• Contract Manufacturing | Molding | R&D & Design | Tubing & Extrusion

  No More Tragedies: An Introduction to ISO 80369

  The international ISO 80369 standard will provide strict guidelines for manufacturers to produce non-interchangeable connectors that only can be used between devices intended for the same clinical application.

  Online Exclusives Laura Dowling 09.14.11
  

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