3D Printing and IP: Can They Coexist?
Analysts have predicted that by 2018, 3D printing will result in a loss of $100 billion per year in IP...
Mar 05 2014,
Regulations
CDRH 2014-2015 Priorities Focus on Clinical Trials and PMAs
CDRH's 2014-2015 Strategic Priorities address the difficulty that manufacturers face in seeking and obtaining regulatory approvals....
Feb 11 2014,
FDA Publishes List of Priorities for 2014
FDA’s Center for Device and Radiological Health issued a list of guidance documents that it intends to publish in FY2014....
Jan 15 2014,
FDA Posts 510(k) Communication Timeline
FDA has developed a timeline that provides 510(k) applicants with an understanding of communication during the review process....
Jan 15 2014,
FDA Promotes Voluntarily Correcting Violations with New Program
FDA recently announced details of a new pilot program that will allow medical device companies to voluntarily identify and correct...
Jan 15 2014,
Auditing Process Validation & Developing Protocols
Have you ever had to perform a process validation protocol for a new piece of equipment or acquired a process...
Jan 15 2014,
The Hague Agreement: It May Save You Money
The Hague Agreement more closely aligns U.S. design patent laws with the international community. It also provides flexibility when filing...
Dec 11 2013,
U.S. OIG Issues POD Report; Reliance Medical Files a Suit
The U.S. Office of Inspector General of the Dept. of Health and Human Services' overview of prevalence and use of...
Dec 11 2013,
National Joint Registry for England, Wales and Northern Ireland: Findings from 10th Annual Report
The NJR Steering Committee launched its tenth report in late September. Data from more than 1.4 million procedures are now...
Dec 11 2013,
CMS Issues Proposed Decision Memo for Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis
The U.S. Centers for Medicare & Medicaid Services proposes that Percutaneous Image-guided Lumbar Decompression for lumbar spinal stenosis is not...
Dec 11 2013,
Postmarket Surveillance and Vigilance: Making Risk-based Decisions
Medical device risk management is not a one-time project. Implementing the following steps will ensure review and risk assessment takes...
Dec 11 2013,
Start Early: Converting Your Spinal Technical File into a Class III Design Dossier
As part of EU Commission regulatory changes, spinal implants will be reclassified from Class IIb devices to Class III devices....
Dec 11 2013,
Mitigate Patent Infringement Risk with an FTO
Performing an FTO search is a critical tool when developing or getting ready to launch a new product. Here's how...
Oct 03 2013,
Risk Management: The Science of Minimizing Uncertainties
The success of a risk management process in medical device manufacture lies in an early start in design and use...
Oct 02 2013,
Presenting Data to Show Product Cost Effectiveness
Shifts in the marketplace are driving a need to collect and position clinical data in order to show product effectiveness....
Oct 01 2013,