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Articles Tagged "risk"

Risk Assessments: How Often Should I Update Them?

by BONEZONE | Oct 2017

Denise Dion from EduQuest provides advice on when to update your risk documentation.... Read more »

Value Analysis Committees: Develop Your Own

by BONEZONE | Aug 2017

The influence of hospital VACs has created a market access risk that you must consider when assessing new technologies—before product development begins. How do you reduce that risk? One idea is to create your own panel of experts—or at the very least, interview experts—that extend beyond the ... Read more »

A Watchful Eye on Device Performance can Decrease Postmarket Surveillance Burdens

by BONEZONE | Jan 2017

Our global industry requires companies to develop harmonized postmarket surveillance systems that minimize inconsistencies in our understanding of product lifecycle risks.... 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 »

3D Printing, Cybersecurity Emerging Concerns for Device Manufacturers

by Hannah Corcoran | Nov 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 »

The Fundamentals of a Human Factors Program

by Hannah Corcoran | Oct 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 »

How to Avoid Risky CAPA Decisions

by John Gagliardi | Mar 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 »

Postmarket Surveillance and Vigilance: Making Risk-based Decisions

by John Gagliardi | Dec 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 »

Risk Management: The Science of Minimizing Uncertainties

by John Gagliardi | Oct 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 »

Making Smarter Product Recall Decisions: 4 Critical Steps to Meeting FDA’s Expectations

by Martin Browning | Dec 2012

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 »

Planning for the Unpredictability of Change

by BONEZONE | Dec 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 »

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 »