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Articles Tagged "13485"

nanoMAG Receives ISO 13485:2016 Certification

by BONEZONE | Mar 2018

The company is a contract manufacturer of engineered biomaterials.... 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 »

Don't Treat Your FDA Inspection Like an ISO Audit

by BONEZONE | May 2017

Good Manufacturing Practices/QS Regulation and ISO 13485:2016 resemble each other with respect to medical device manufacturing and design quality systems. Despite the similarities, it is the interpretation and the approach of the investigator or the auditor that makes the experience very different.&... 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 »

Autocam Medical Suzhou, China Facility Registered to ISO 13485

by BONEZONE | Dec 2016

Initial registration is to ISO 13485:2003, but upgrade to ISO 13485:2016 expected by next surveillance audit.... 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 »

Supply, Cost and Quality Lead Concerns among Raw Materials Providers

by BONEZONE | Mar 2016

Supply and demand factors, price pressures and enhanced regulatory scrutiny are expected to influence the raw materials portion of the orthopaedic supply chain in 2016. Eight of the 27 raw material suppliers exhibiting at OMTEC weighed in on these themes.... Read more »

The Revitalized ISO 13485: Ready for Business

by BONEZONE | Feb 2016

The ISO 13485:2016 Standard is slated for publication in March 2016. Consider these eight changes when updating your certification.The internationally-recognized medical device industry quality management systems (QMS) standard has been under revision since 2010. The newest version of ISO 13485 (201... Read more »

The Top Industry News from 2015

by BONEZONE | Jan 2016

Need a refresher on compliance initiatives and industry-shaping events? We’ve recapped the six most-read articles of 2015.... 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 »

Vulcanium Achieves ISO 13485 Registration

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 »

Barger Demonstrates Quality Excellence with ISO 13485 Certification

by BONEZONE | 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 »

Oberg Costa Rica Receives ISO 13485 Certification

by BONEZONE | Nov 2014

Oberg Costa Rica has achieved ISO 13485:2003 certification from the British Standards Institution. (Source: Oberg Industries)... Read more »

AccuRounds Achieves ISO 13485:2003 Certification

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 »

VSMPO‐Tirus, US and NF&M International Receive ISO 13485 Certification

by BONEZONE | Feb 2014

Source: VSMPO-Tirus, US VSMPO‐Tirus, US announced today that the titanium company along with its subsidiary NF&M International have received ISO 13485:2003 certification for the company's quality management system. ISO 13485 is the premier quality certification for the manufacture of medical d... Read more »

Baum Precision Machining Earns ISO 13485 Certification

by BONEZONE | Jan 2014

SRI Quality System Registrar is pleased to announce that it has awarded an ISO 13485:2003 Management System certificate to Baum Precision Machining, Inc., located in Pipersville, Pennsylvania, for the manufacture of general nonactive, non-implantable, medical devices and non-active im... 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 »

Forecreu France Achieves ISO 13485:2003 Certification

by BONEZONE | Jul 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 »

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 »

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 »

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 »

UFP Technologies Awarded ISO 13485:2003 Certification

by BONEZONE | Jan 2013

UFP Technologies has been awarded ISO 13485:2003 certification at its Denver, CO, El Paso, TX and Grand Rapids, MI manufacturing facilities.  UFP Technologies serves the medical industry by designing and manufacturing custom components and specialty packaging from advanced foams, plastics, and... Read more »

PPD Meditech Announces Expansion of Manufacturing Facility

by BONEZONE | Jun 2012

PPD Meditech, a global outsource manufacturer for the orthopedic industry, completed a major facility and capacity expansion in Waterville, Quebec, Canada, doubling the company's manufacturing space to ~20,000 square feet.  The expansion was driven by growing demand for the company's proprietar... 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 »