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Testing
Plastikos and Plastikos Medical Implements ISO 14698
This system is dedicated to test for bio-contamination, and evaluate microbiological data.Plastikos 04.01.20
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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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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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The ISO 13485:2016 Transition Journey
Results of an ASQ Biomedical Division survey on the move to the new standard are shared.Jim Shore, Chair-Elect, ASQ Biomedical Division 06.04.18
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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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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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Molding | R&D & Design | Tubing & Extrusion
No More Tragedies: An Introduction to ISO 80369
No More Tragedies: An Introduction to ISO 80369Laura Dowling 05.10.11
