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 "iso"

J-Pac Medical Receives ISO:13485:2016 Registration Ahead of Schedule

by BONEZONE | Dec 2017

ISO 13485:2016 has a greater emphasis on risk management and risk-based decision making.... 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 »

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 »

ASTM International Seeks Partners to Launch Additive Manufacturing Center of Excellence

by BONEZONE | Nov 2017

This global innovation hub will advance AM technical standards, related research and development, education, training and more.... Read more »

Autocam Medical’s Massachusetts Facility Recertified to ISO 13485:2016

by BONEZONE | Oct 2017

The recertification represents the company's continued investment in its quality management system... Read more »

Precision ADM Receives ISO 13485 Certification

by BONEZONE | Sep 2017

Precision ADM is the first Canadian supplier of metal additive and subtractive manufacturing to receive this certification.... 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 »

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 »

Okay Industries Expands CNC Machining, Earns 13485 Registration

by BONEZONE | Sep 2013

Okay Industries enhanced its CNC machining capabilities with the addition of a Miyano BND 51 five axis lathe and a Tsugami SS207 5AX nine axis Swiss machine with a fully programmable B axis. Okay further added CAM software and earned its ISO 13485 registration for both its New Britain and Berlin, C... Read more »

Cadence Facility Receives 13485:2012 and ISO 9001:2008 Certification

by BONEZONE | Jun 2013

Cadence, a provider of medical device outsourcing solutions, received ISO 13485:2012 and ISO 9001:2008 certification through BSI for its Pittsburgh, Pennsylvania location.  Cadence's new facility offers turnkey finished medical device assembly and sterilization management capabilities, allowin... Read more »

Ceram Awarded ISO 14001 Certification

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 »

Arcam is now ISO 9001:2008 Certified

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 »

What if Your ISO Auditor is Wrong?

by Robert Packard | Apr 2013

Auditors are human. The question is: What should you do when they're wrong?... Read more »

MDI Announces ISO 13485 Certification

by BONEZONE | Feb 2013

MDI, contract manufacturer of orthopedic and spinal implants, has achieved ISO 13485 certification. (Source: Medical Device and Implants, LLC)... Read more »

BSI Enhances its Medical Device Training Curriculum with RABQSA

by BONEZONE | Sep 2011

RABQSA International (RABQSA) and BSI Group America have co-developed an innovative Medical Devices training curriculum, created for individuals wishing either to become trained to audit to the Medical Devices Standard (ISO 13485) or simply to understand the requirements of a medical devices quality... 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 »

MDD Regulations: What I Wish I Had Known

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 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: 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 »