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ISO 13485 Remote Audits: Views from Both Sides of the Table
Remote audits have been a standard practice for low-risk suppliers or in the cases where restrictions existed in entering certain parts of the world.Jim Shore, Quality Lean Solutions, and Neel Patel, Florida Anodize System & Technologies 06.04.20
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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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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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Compounding Solutions Receives ISO 13485:2003 Quality Certification
The company had previously been certified to the ISO 9001:2008 standard.Compounding Solutions 12.20.16
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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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Contract Manufacturing | Molding | R&D & Design | Tubing & Extrusion
No More Tragedies: An Introduction to ISO 80369
The international ISO 80369 standard will provide strict guidelines for manufacturers to produce non-interchangeable connectors that only can be used between devices intended for the same clinical application.Online Exclusives Laura Dowling 09.14.11
