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Able Medical Devices Receives ISO 13485 Certification
The company's facility is fully equipped with technology supporting product development, prototypes, and contract manufacturing.Able Medical Devices 01.24.19
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Insulet’s Omnipod DASH Insulin Management System Receives ISO 27001 Certification
The insulin pump is the only device of its kind to receive both ISO 27001 and DTSec certifications.Business Wire 01.10.19
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SoftServe Achieves ISO 13485 Certification
International standard ensures customer and regulatory requirements are met for the lifecycle of medical device products.Globe Newswire 01.07.19
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Sensera Achieves ISO 13485 Quality Certification
The company previously achieved ISO 9001:2015 certification in 2017.Business Wire 11.06.18
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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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MDI receives ISO 13485:2016 Certification
Nearly half the company’s employees are people with disabilities.MDI 07.27.18
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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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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
