Thanks! You've successfully subscribed to the BONEZONE®/OMTEC® Monthly eNewsletter!

Please take a moment to tell us more about yourself and help us keep unwanted emails out of your inbox.

Choose one or more mailing lists:
BONEZONE/OMTEC Monthly eNewsletter
OMTEC Conference Updates
Advertising/Sponsorship Opportunities
Exhibiting Opportunities
* Indicates a required field.

Articles Tagged "testing"

Crucial Validation Considerations for Instrument Cases and Trays

by BONEZONE | Oct 2018

Common challenges device company engineers face during validation of delivery systems include case/tray longevity, robustness of design, maintaining integrity of ID markings and establishment of worst-case testing parameters. ... Read more »

Zwick Roell Expands Line of Linear Testing Machines

by BONEZONE | Aug 2018

The LTM line of testing systems features an electro-dynamic drive based on linear motor technology.... Read more »

Nelson Laboratories Purchases Gibraltar Laboratories

by BONEZONE | Aug 2018

This acquisition expands the U.S.-based analytical testing capabilities of Nelson Laboratories.... Read more »

Nelson Laboratories Expands Operations, Testing Capabilities

by BONEZONE | Apr 2018

Service capacity is doubling at the company’s Itasca, Illinois lab.... Read more »

Are You Capturing the Right Inspection Information?

by BONEZONE | Feb 2018

By recording actual results, instead of pass/fail, you can better investigate failures that may occur in production/post-production. This approach also helps to verify the specification you originally developed is appropriate and effective for your products.... Read more »

FDA Finalizes Additive Manufacturing Guidance

by BONEZONE | Dec 2017

FDA published its guidance on additive manufacturing technical considerations, outlining the Agency’s long-awaited position on use of the technology for medical devices.... Read more »

Knight Mechanical Testing and A-kit America Announce Merger

by BONEZONE | Dec 2017

The combined company – called JTL America – will offer expanded mechanical and analytical testing capabilities for the orthopaedic and automotive industries.... 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 »

Why a Well-Conceived Test Plan is Crucial to Efficient Product Development

by BONEZONE | Dec 2017

The elements are derived from the biological, mechanical or clinical performance requirements of the device and regulatory requirements for performance and safety.... Read more »

Titanium Powder for Additive Manufacturing Shows Increased Strength

by BONEZONE | Nov 2017

CarTech Puris 5+ exceeds the standard Ti 6Al-4V Grade 5 strength levels by nearly 18%.... 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 »

DEKRA Expands Lab for Material Testing and Damage Analysis

by BONEZONE | Jul 2017

A new field emissions SEM produces high-resolution images above 120,000 times magnification, allowing more in-depth insights than conventional devices.    ... 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 »

When Do I See a CAPA Specialist?

by BONEZONE | May 2017

If your company struggles with deciding when to elevate a complaint to the level of a CAPA, how do we differentiate between complaints, non-conformances and CAPAs? Our experts respond.... Read more »

Design Intent: Do I Need to Perform Verification and Validation?

by BONEZONE | Apr 2017

If you’ve characterized a material change to your medical device and confirmed no impact to any of your design inputs or outputs, do you have to formally perform verification and validation? Our experts respond.... Read more »

Element Materials Technology Acquiring Medical Device Testing Services

by BONEZONE | Apr 2017

U.S.-based MDT's services include Orthopaedic Device Fatigue Testing, Corrosion Testing and Particulate Counting and Analysis.   ... 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 »

Zwick Introducing LTM Products for Device Testing

by BONEZONE | Feb 2017

Commercialization of Zwick’s LTM 5 and LTM 10 stemmed from direct customer feedback.... Read more »

Medical Device Testing Services Expands Orthopaedic Capabilities

by BONEZONE | Sep 2016

The contract test lab now offers spine and knee wear testing.... Read more »

3D Systems Launches New Inspection Capabilities with Geomagic Control X Software

by BONEZONE | Sep 2016

This software update supports precise, rapid digital inspection for quality management and metrology workflows.... Read more »

Boston Centerless Adds a Material Validation Center

by BONEZONE | Sep 2016

The new center supports the ability to verify the identity and integrity of the precision bar products, mitigating material risk.... Read more »

When to Contract Your Device Testing

by Chris Mosby | Aug 2016

All medical devices must be tested. However, the varied aspects of device testing can be unfamiliar ground, and standards are often vague guidelines, open to interpretation.... Read more »

The Advantage of Adverse Event Wear Testing

by Gemma Budd | Aug 2016

Advances in the development of prosthetic joints and materials have led to a need for more effective testing solutions to drive the development of new and improved implants.... 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 »

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 »

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 »

New Factors Challenge Traditional Testing Requirements

by Hannah Corcoran | Aug 2015

For orthopaedic device manufacturers, new concerns are cropping up during the device testing process due to regulatory changes and the emergence of new materials and technologies in the industry.... Read more »

Lucideon Now Performs Orthopaedic Implant Impingement Testing

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 »

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 »

Lucideon Launches Digital Image Correlation Service – 3DStrain

by BONEZONE | Apr 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 »

Lucideon Receives ISO 17025 Accreditation for Wear Testing

by BONEZONE | Apr 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 »

Lucideon Doubles Wear Testing Capabilities in the U.S.

by BONEZONE | Apr 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 »

Accutek Joins Forces with Element Materials Technology

by BONEZONE | 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 »

Lucideon to Bolster U.S. Presence

by BONEZONE | Oct 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 »

Talyrond 585 Metrology Tool Plays Key Role in Retrieved Hip Implant Analysis

by BONEZONE | Sep 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 »

Lucideon Announces Collaboration with Knight Mechanical Testing

by BONEZONE | Sep 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 »

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 »

Lucideon Now Offers Testing and Debris Analysis for Implant Manufacturers

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 »

Empirical Testing: Celebrating 15 Years with Expansion of Services

by BONEZONE | 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 »

Ace Your Next Test

by BONEZONE | 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 »

Ceram Releases Testing Video

by BONEZONE | May 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 »

Accutek Weighs In on the State of Testing

by BONEZONE | May 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 »

Manufacturing Implants with Residual Compression

by Doug Hornbach | May 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 »

FDA Recognizes Computer Simulated Performance Data in Device Evaluation

by BONEZONE | 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 »

Ceram Now Offers Microbiology Testing

by BONEZONE | 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 »

Ceram Adds Biocompatibility Testing to its Analysis Services

by BONEZONE | Mar 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 »

Lessons Learned From Metal-on-Metal Implants

by Robert Packard | Mar 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 »

AV&R Vision & Robotics Finalist in ARDIQ 2012 Innovation Prize

by BONEZONE | Oct 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 »

Mark-10 Introduces Updated Programmable Force Tester with PC Control

by BONEZONE | Jun 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 »