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Articles Tagged "audit"

Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies

by BONEZONE | Dec 2017

While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA named it an official program earlier in 2017.   ... Read more »

Understanding the Critical Differences Between Supplier Audit and Evaluations

by BONEZONE | Dec 2017

Martin Browning from EduQuest provides insight on evaluations and audits: "All of us who conduct audits recognize that most of them are nothing more than snapshots in time. In contrast, an evaluation gathers and analyzes data from all kinds of sources, without physical constraints associat... Read more »

Top Tools to Qualify Suppliers

by Robert Packard | Jan 2017

When an OEM specifies weak second-tier suppliers, its first-tier suppliers have fewer resources to devote to its own internal processes. One weak link can prevent the best outcome from occurring. This six-step program helps OEMs ensure that they’re recommending top suppliers throughout the chain.... Read more »

How Often Should You Audit Your Suppliers?

by BONEZONE | Jan 2017

EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, the experts offer Supplier Auditing insight.... Read more »

Building Your Bridge to the Island of ISO 13485:2016

by John Gagliardi | Nov 2016

Medical device companies have until March 1, 2019 to update their quality management systems to the ISO 13485:2016 standard. The simultaneous introduction of the Medical Device Single Audit Program and transitions to ISO 9001:2015 will leave manufacturers busy and certification bodies slammed. There... Read more »

The Basics: Understanding the Medical Device Single Audit Program

by Robert Packard | Feb 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 »

Webinar: Making Your Management Review Meetings More Effective

by BONEZONE | Mar 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 »

Auditing Process Validation & Developing Protocols

by Robert Packard | Jan 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 »

Six Steps to ISO 13485 Certification

by Robert Packard | May 2013

ISO 13485 Certification is the quickest pathway to achieving CE Marking approval. Manufacturers should follow these sequential steps as a roadmap to certification.... Read more »

Entering the Market in Argentina

by BONEZONE | Feb 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 »

Hammill Manufacturing Completes Recent FDA Inspection

by BONEZONE | Feb 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 »

Develop Orthopaedic Implants Faster Through Auditing

by Robert Packard | Feb 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 »

Six Steps to Qualifying Suppliers

by Robert Packard | Jan 2013

If an OEM specifies weak second-tier suppliers, its first-tier suppliers will have fewer resources to devote to its own internal processes. One weak link can prevent the best outcome from occurring. This six-step program helps OEMs ensure that they’re not recommending inferior suppliers anywhe... Read more »

The Internal Quality Audit Process for Orthopaedic Medical Device Companies: Risk Indicators and Uncertainties

by BONEZONE | Aug 2011

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 »