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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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Boyd Corporation Announces ISO 13485:2016 Certification of Southern Asia Facility
Company expands its medical Quality Management Systems for medical devices in South Asia.Business Wire 08.29.19
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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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Materials
Bally Ribbon Mills Receives ISO 13485:2016 Certification
Recertification reflects commitment to supplying highest quality medical products.Bally Ribbon Mills 01.17.19
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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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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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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
