Search Results for 'iso'
Buyers Guide Companies
Microsite Companies
Featured Companies
View All Buyers Guide Companies »
Buyers Guide Categories
View All Categories »
-
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
-
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
-
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
-
Digital Health | Software & IT
Galen Data Awarded ISO 13485:2016
Certification positions company’s cloud-based connected medical platform solution for growth.Galen Data 01.16.19
-
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
-
MDI receives ISO 13485:2016 Certification
Nearly half the company’s employees are people with disabilities.MDI 07.27.18
-
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
-
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
-
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
-
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
