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Articles Tagged "medical device"

Protecting Your Design with Patents

by BONEZONE | May 2018

A smart legal strategy is to develop a comprehensive intellectual property portfolio of the various diverse—but related—IP rights associated with the inventive device.... Read more »

Successful Medical Device Design Transfers Hinge on Advance Planning

by BONEZONE | Apr 2018

Elements of a well-constructed plan include an understanding of regulatory requirements, a comprehensive review of all documentation and a thorough understanding of manufacturing methods and processes.... Read more »

FDA and Customs Monitoring of International Purchasing: What You Need to Know

by BONEZONE | Apr 2018

The ultimate goal is to ensure that all medical device products manufactured or distributed in the U.S. are both safe and effective for human use. ... Read more »

Gauthier Biomedical Gains FDA Clearance for Intellitorq Electronic Torque Indicating Driver

by BONEZONE | Mar 2018

The company is the first to receive 510(k) clearance for an electronic torque indicating device.... Read more »

AcceLINX Adding Three Experts to Consultant Roster, Collaborating With AMB Surgical

by BONEZONE | Mar 2018

The musculoskeletal health business accelerator adds expertise focused on manufacturing/operations, reimbursement and grant writing.... Read more »

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 »

Spine, Trauma Companies Continue a Focus on Sterile Packaging

by BONEZONE | Mar 2018

Increased infection rates at hospitals, regulatory implications on cleaning and the efforts of hospitals to cut costs have all driven sterilization changes in device packaging.... 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 »

Total Plastics International, Restoration Medical Polymers Enter Into Distribution Agreement

by BONEZONE | Feb 2018

RMP manufactures UHMWPE used in long-term human implantable applications, especially those in the orthopaedic industry.... Read more »

Tegra Medical Expanding Sales to Europe

by BONEZONE | Jan 2018

The company has also named Mr. Neil Garner as European Business Development Manager... 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 »

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 »

Learn to Incorporate Sensors Into Your Next Design Idea

by BONEZONE | Dec 2017

Microelectromechanical Systems, referred to as MEMS devices or sensors, are being used for tasks that were previously only conceived of in science fiction.... 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 »

What Great Product Managers Can Teach Us About Our Work

by Carolyn LaWell | Jan 2017

What is your individual product? What do you create, day in and day out, for your colleagues and your customers? Applying lessons in communication, decision making and strategy from great product managers may spur new ideas for ways to think in an even bigger picture.... Read more »

FDA Update: Final Guidance on Medical Device Reporting

by BONEZONE | Jan 2017

FDA has issued final guidance on Medical Device Reporting (MDR) for Manufacturers. The goal of the guidance, says FDA, is to detect and correct device problems in a timely manner.... Read more »

Big Data Tops FDA’s 2016 Priorities

by Carolyn LaWell | 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 »

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 »

Survey Finds Most Med Device Companies Have Positive Outlook for 2015; Same Challenges Remain

by Hannah Corcoran | Feb 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 Basics: Understanding the Medical Device Single Audit Program

by Robert Packard | Feb 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 Get the Most Out of Your IP Firm

by John W. Boger, Esq. | Dec 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 »

MRPC Completes Facility Expansion on the Heels of Top Workplaces Win

by BONEZONE | Jun 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 »

CDRH 2014-2015 Priorities Focus on Clinical Trials and PMAs

by BONEZONE | Feb 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 »

FDA Promotes Voluntarily Correcting Violations with New Program

by BONEZONE | 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 »

The Anatomy of a Successful Design Plan

by Robert Packard | 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 »

Spotlight on Europe

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 »

Just Because You’re Trained, Doesn’t Mean You’re Competent

by John Gagliardi | 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 »

Strategic Company Financials: Orthopaedics and Spine

by Julie A. Vetalice | 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 »

Strategic Orthopaedic 510(k) Update

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 »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Feb 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 »

Secant Medical appoints Jacqueline Ferro as Vice President, Quality and Regulatory Assurance

by BONEZONE | Feb 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 »

The Ohio State University, Cleveland Clinic Form Alliance To Focus On Accelerated Commercialization

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 »

Supply Chain Development in Orthopaedics

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 »

Polymer Composite May Eliminate Bone Formation in Soft Tissue

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 »

The Ohio State University, Cleveland Clinic Form Alliance to Focus on Accelerated Commercialization

by BONEZONE | Jul 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 »

Precision Engineered Products Expands Medical Manufacturing Capability with New Dominican Republic Facility

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 »

Join Gibraltar Laboratories in October 2012 for Seminar on Antimicrobial Practice

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 »

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 »

Basic Anatomy of a Design Dossier

by BONEZONE | Mar 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 »