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Articles Tagged "quality management"

Examining Methods to Determine Sample Sizes

by BONEZONE | Dec 2017

Consider use of the acceptance sampling approach or the six sigma acceptable error approach to determine a sample size using statistics.  ... Read more »

Design Validation: More than Just User Testing

by BONEZONE | Aug 2017

EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, Denise Dion, Vice President of Regulatory & Quality Services for EduQuest, corrects a common misconception.... Read more »

Proving Your New Design is Production Equivalent

by BONEZONE | Jun 2017

Design validation is essential to new product development, especially when using multiple suppliers to manufacture your device. Our experts weigh in on how to determine your product is production equivalent.... Read more »

Don't Treat Your FDA Inspection Like an ISO Audit

by BONEZONE | May 2017

Good Manufacturing Practices/QS Regulation and ISO 13485:2016 resemble each other with respect to medical device manufacturing and design quality systems. Despite the similarities, it is the interpretation and the approach of the investigator or the auditor that makes the experience very different.&... Read more »

Lowell Adds Quality Manager

by BONEZONE | May 2016

Lowell announced that Ed Yaris has joined the company as its Quality Manager. Yaris comes to Lowell with experience in Metrology, Management and CMM Software development, including leadership positions at National Security Technologies, Helmel Engineering Products, Renishaw and GE. Yaris is a membe... Read more »

FDA Outlines Critical Quality Measures

by BONEZONE | Sep 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

ISO 9001 Drastically Revised

by Robert Packard | Aug 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Purchasing Controls: Draft the Best Supplier Quality Agreement

by John Gagliardi | Jul 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Getting Lean: Strive for Built-in-Quality

by BONEZONE | Jul 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Big Changes in ISO 13485:2015?

by Robert Packard | May 2015

On February 5, 2015, a second draft of ISO 13485 was released to the world for comment. How will new quality system requirements in the latest version of ISO 13485 affect you?... Read more »

ISO 55000 Released to Assist Operations Leaders with Financial Management

by Randy W. Rapin | Jan 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Six Ways to Prevent Supplier Quality Problems

by Robert Packard | Jun 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

How to Build a Better Supplier Scorecard

by Robert Packard | Nov 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Just Because You’re Trained, Doesn’t Mean You’re Competent

by John Gagliardi | Apr 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »