Process Validation Requires that You First Determine Scope
What is the current industry thinking on process validation? Our Ask the Experts series posed to the question to Carolyn...
Sep 23 2019,
Regulations
Complaints and Clinical Evaluations: What Reporting Actions Should You Take?
Regulatory and quality orthopedic professionals offer advice on ways that they would manage the gray areas of complaint reporting and...
Sep 06 2019,
Computational Modeling Gets Boost from ASME Standard, FDA Science Priority
A new standard and FDA’s regulatory science priorities focus on computational modeling & simulation, which provide indication that orthopedic device...
Sep 06 2019,
3 Testing Companies Advise How to Handle Evolving Requirements
Orthopedic device companies should proactively ask FDA and other regulatory bodies about important testing requirements and changes to regulations and...
Aug 05 2019,
CMS Proposes Total Knee and Total Hip Outpatient Changes
The Center for Medicare and Medicaid Services announced its recommendation to cover total knee replacement in ASCs and total hip...
Aug 02 2019,
A Solid Quality System Will Help You Adapt to Changing Regulations
Incorporate sound quality management systems into the production of new products and processes so that regulations become guiding principles for...
Jul 22 2019,
FDA Challenges Industry to Find Sterilization Alternatives after Sterigenics, Viant Announce Facility Closures
FDA's study of new sterilization methods is in response to ethylene oxide sterilization facility closures. The closures were promoted by...
Jul 19 2019,
Engineers: Don’t Let Increased Regulatory Requirements Slow Your Design Process
Adhering to best practices allows engineers to work effectively within parameters of the regulations and plan projects in a way...
Jun 03 2019,
FDA’s Pre-Submission Process Allows You to Minimize Risk and Decrease Cost
Utilizing FDA's Pre-Submission Process provides an opportunity to address potential concerns early in the regulatory process, and it can significantly...
May 20 2019,
UDI Convenience Kit Guidance Released by FDA
FDA finalized UDI guidance for convenience kits and provided orthopedic-specific examples as context in the document....
May 06 2019,
FDA Finalizes Guidance for UHMWPE used in Orthopedic Devices
FDA released guidance regarding the characterization of ultrahigh molecular weight polyethylene (UHMWPE) used in orthopedic devices, providing manufacturers direction in...
May 06 2019,
UDI Laser Marking Improved with Vision Technology
Today’s laser marking technology has advantages and limitations depending upon your type of orthopedic part and your budget. A Unique...
Apr 23 2019,
FDA Targets Device Materials, Releases Metal-on-Metal Study Results
FDA is looking at materials used in medical devices, citing growing evidence that a small number of patients may have...
Apr 19 2019,
EU MDR: How to Respond to Today’s Knowns and Unknowns
Orthopedic device companies implementing EU MDR should consider these eight actions, while thinking strategically about the unknowns of the regulation. ...
Apr 19 2019,
FDA Proposes Framework for Artificial Intelligence-Based Devices
Artificial intelligence technology is evolving quickly, and the potential benefits of adaptive AI systems in relation to modern medicine are...
Apr 08 2019,