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Articles Tagged "quality management"

Slideshow: 6 Supplier Startups

by BONEZONE | Oct 2020

New suppliers and service providers are being established to assist OEMs in important areas like additive manufacturing, materials, manufacturing efficiency and quality.... Read more »

Greenlight Guru Launches Tool to Support Closed-Loop Traceability

by BONEZONE | Sep 2020

New machine learning-powered capabilities provide device makers with instant visibility into the connections and relationships of their quality system.   ... Read more »

Keys to an Effective Additive Manufacturing Quality System

by Kathie Zipp | Jun 2020

FDA and Stryker joined an additive manufacturing panel to discuss the importance of quality systems and industry and regulator collaboration.... Read more »

7 Steps You Need to Follow to Develop a Quality Culture

by Jon Speer | Mar 2020

There’s a difference between meeting quality regulatory standards and fostering a quality culture in your device company. This guide walks you through the development, implementation and maintenance of a quality culture.... Read more »

This is What it Takes to be Competitive in Today's Medical Device Market

by Heather Tunstall | Feb 2020

Findings from a new survey of 524 medical device professionals can help you benchmark yourself against best-in-class companies in the areas of product and quality management.... Read more »

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

During his OMTEC presentation, Joe Mazzeo pinpointed the principles necessary to build a culture of inherent quality, stressing strong leadership and cultural tenets to drive lean manufacturing and create value.... 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 »