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  PrinterPrezz Announces ISO 13485:2016 Certification for 3D Printing of Medical Devices

  Certification represents an important milestone for the company that reflect its emphasis on safety and providing high-quality devices.

  Business Wire 08.07.19
  

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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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• Machining & Laser Processing
  

  Precision Micro Secures ISO 13485 Accreditation

  Photochemical etching specialists attain the stringent standard in less than 12 months.

  Precision Micro 03.12.19
  

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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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  DirectMed Parts & Service Receives ISO 13485 Certification for MRI, CT Parts and Service

  The achievement is in addition to the company’s ISO 9001:2015 certification.

  Business Wire 04.05.18
  

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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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  A Look into ISO 14971: Risk Management and Quality System Integration

  “People generally prefer present benefits over future benefits, and prefer future harms over present harms, so time-preference may need to be captured when risks and benefits occur at different times,” stated an Association for the Advanc…

  Emily Ysaguirre, VERSE Solutions 07.26.17
  

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