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Articles Tagged "validation"

Medical Device Packaging is Shaped by Increased Regulations

by BONEZONE | Mar 2018

Global unique device identification (UDI) and ISO updates are among the regulations and standards that companies must monitor in the coming years.... Read more »

Vital Validation Considerations for Your Company's Next Packaging Project

by BONEZONE | Mar 2018

Common problems that OEMs face during packaging validation include determining what validations are actually necessary, understanding all timelines and costs associated with each validation type and re-executing if validation fails. ... Read more »

The Medical Device Labelling Process Needs to Start Early in Design Controls

by BONEZONE | Mar 2018

Mislabeled and misbranded medical devices are one of the top three causes for recalls in the United States. Companies can take several steps to minimize these mistakes — it comes down to being in control.... Read more »

Computational Modeling and Simulation Expanding in Orthopaedic Device Life Cycles

Computational modeling and simulation (CM&S) can revolutionize medical devices by accelerating innovation and providing evidence of long-term safety.... 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 »

Pareto Analysis: Tools for New Product Testing

by BONEZONE | May 2017

Testing is, of course, a critical component to product development. To better understand how it can be proactively employed to help ensure product quality and longevity, we reached out to John McCloy, Founder & President of Engineered Assurance and author of the article on the industry’s 1% fa... Read more »

Reducing the 1% Failure Rate through Testing & Analysis

by John McCloy | Mar 2017

John McCloy offers solutions to reducing the 1% failure rate of medical implants through testing & analysis... Read more »

Instrument Testing: How to Capture the Best Data

by BONEZONE | Jul 2016

Vagueness in standard methods and regulatory guidance surrounding instrument testing and validation has left OEMs questioning what best practices to apply to their devices.... Read more »

TSO3 Offers Single-Cycle Sterilization of Heavy-Duty, Battery-Powered Orthopaedic Instrument Sets

by BONEZONE | Jul 2016

TSO3 completed sterile efficacy validation for multiple heavy-duty battery-powered orthopaedic instrument sets in a single sterilization cycle.... Read more »

Lucideon to Host Cleanliness of Reusable Devices Webinar

by BONEZONE | May 2016

Lucideon will host a webinar titled Cleaning Validation of Reusable Medical Devices on June 9 at 10 a.m. (EST). Medical devices need to be cleaned thoroughly and effectively to ensure their safety in use. Reusable devices (such as surgical tools) require reprocessing (cleaning and disinfection/ster... Read more »

FDA Releases Final Guidance on Human Factors and Usability Engineering

by BONEZONE | Apr 2016

The Agency released the final guidance on considerations for human factors data in premarket submissions, as well as two draft guidances on the topic.... Read more »

8 Design Control Issues Found During FDA Inspections

by John Gagliardi | 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 »

OEMs Weigh in on Managing Supplier Quality

by BONEZONE | 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 »

Master Your Sterilization Process

by BONEZONE | 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 »

How to Proceed When a Testing Standard Doesn’t Exist

by Carolyn LaWell | 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 »

Nelson Laboratories Joins the Orthopedic Discussion on Sterile Packaging Validation at OMTEC 2014

by BONEZONE | May 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 »

Sterilization: How to Validate Novel and Non-Traditional Processes

by Robert Packard | Apr 2014

Novel and non-traditional sterilization processes offer alternatives that enable manufacturers to consider new polymer materials that are not compatible with traditional sterilization methods. Here is a look at the tools and standards for sterilization validation.... Read more »

Synergetic Dissimilarity: Design Validation/Verification and Process Validation

by John Gagliardi | Mar 2014

Verification and validation are commonly confused. John Gagliardi defines the intertwined engineering tools and outlines how they are practiced.... 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 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 »

Quality by Design: Incoming Acceptance Activities of Purchased Materials

by John Gagliardi | Aug 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 »

Integrating Internal Strategies to Impact a Successful Product Launch

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 »

Design Controls: Design Verification and Validation

by BONEZONE | Sep 2010

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 »

Design Controls: Design Review

by BONEZONE | Jun 2010

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 »

Design Controls: Inputs and Outputs in Synergy

by BONEZONE | Mar 2010

This is the third in a series of articles focused on the design controls process from a standpoint of business acumen as well as meeting customer requirements in the orthopaedic medical device market. Sometimes called the requirements phase, design inputs are the starting point of understanding the ... Read more »