OEMs Weigh in on Managing Supplier Quality
OEMs tackled the topic of supplier quality during a panel discussion, including supplier approval, development and priorities....
Aug 12 2015,
Competitive Landscape
Executives Warn of Paradigm Shift in R&D Spend
The keynote addresses at OMTEC 2015 highlighted the bottleneck between product development and product adoption....
Aug 11 2015,
CMS Targets Hip and Knee Reimbursement
The U.S. Centers for Medicare & Medicaid Services (CMS) proposed a bundled payments program to accelerate value-based care that, once...
Aug 11 2015,
Master Your Sterilization Process
At OMTEC® 2015, Jozef Mastej, Vice President of Operations, Gibraltar Laboratories, Inc. outlined the cleaning and sterilization validation process for...
Aug 11 2015,
Smith & Nephew’s Syncera Focuses on Organization of OR Instruments
Smith & Nephew’s Syncera business unit acquired two assets from S2 Interactive, a surgical software development company, to offer customers...
Aug 11 2015,
Demand to Reduce Consigned Inventory Leading to Instrumental Changes in OR
Device manufacturers increasingly seek to streamline their instrument inventories, due to top down demands for simpler, more cost-effective solutions. These...
Aug 11 2015,
New Factors Challenge Traditional Testing Requirements
For orthopaedic device manufacturers, new concerns are cropping up during the device testing process due to regulatory changes and the...
Aug 11 2015,
ISO 9001 Drastically Revised
The ISO 9001:2015 standard is a major revision that will require significant time and resources to determine the best way...
Aug 11 2015,
The Dos and Don’ts of Trademark Registration
The investment of time and money to obtain trademarks may take a significant hit if the respective trademarks are not...
Aug 10 2015,
New UDI Draft Guidance Addresses Direct Marking of Reprocessed Devices
FDA’s most recent UDI draft guidance, Unique Device Identification: Direct Marking of Devices, addresses common questions posed by labelers preparing...
Jul 01 2015,
Purchasing Controls: Draft the Best Supplier Quality Agreement
Quality agreements are an essential management tool to prevent supply chain problems. The best contracts clearly define the extent of...
Jul 01 2015,
Regulatory Expert Builds Web Tool to Assist Companies with 510(k)s
Frustrated with FDA’s 510(k) search function, Eric Eggers created kBLASTER to help companies simplify and speed their 510(k) submissions....
Jul 01 2015,
How to Proceed When a Testing Standard Doesn’t Exist
Orthopaedic device innovation is evolving, and there will be gaps in device testing standards and guidance. Here are three proactive...
Jul 01 2015,
Zimmer Closes Biomet Acquisition
Zimmer has completed its acquisition of Biomet to form the world's second-largest orthopaedic device company, with estimated market...
Jun 24 2015,
FDA Outlines Stance on ex-U.S. Clinical Data
In a recent draft guidance, FDA describes what device companies should consider when submitting OUS clinical data for regulatory approval...
Jun 09 2015,