CMS Proposes Total Joint Bundled Payment, Outpatient Payment Changes
The Centers for Medicare & Medicaid Services (CMS) released two proposals related to total joint reconstruction that could impact procedure...
Aug 31 2017,
Regulations
Design Validation: More than Just User Testing
EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, Denise Dion, Vice President of...
Aug 07 2017,
Reimbursement Tips: Four Things Payors Want
The complexity of reimbursement may be great, but the burden may be lessened if you begin with the end in...
Jul 11 2017,
Want to Talk About Your Invention? Follow These Five Rules
Before you show your invention or share your idea, get familiar with these five rules to protect yourself and your...
Jul 10 2017,
Device Recalls: Prepare for the Unexpected to Minimize Operational and Fiscal Damage
While no company expects to undergo a FDA recall, preparatory steps can decrease the costly and lengthy process of removing...
Jun 06 2017,
Proving Your New Design is Production Equivalent
Design validation is essential to new product development, especially when using multiple suppliers to manufacture your device. Our experts weigh...
Jun 05 2017,
Don’t Treat Your FDA Inspection Like an ISO Audit
Good Manufacturing Practices/QS Regulation and ISO 13485:2016 resemble each other with respect to medical device manufacturing and design quality systems....
May 16 2017,
When Do I See a CAPA Specialist?
If your company struggles with deciding when to elevate a complaint to the level of a CAPA, how do we...
May 08 2017,
Design Intent: Do I Need to Perform Verification and Validation?
If you’ve characterized a material change to your medical device and confirmed no impact to any of your design inputs...
Apr 11 2017,
Clinical Data and CE Mark: What are We Doing Wrong?
A reader informed us that companies are failing the clinical evaluation portion of the initial CE Mark or audit process,...
Mar 27 2017,
Once an Easy Path, Europe’s Regulatory Approval Toughens
Enactment of the EU's Medical Device Regulations is expected to increase challenges for orthopaedic companies seeking CE Mark Approval....
Mar 07 2017,
FDA Update: Final Guidance on Medical Device Reporting
FDA has issued final guidance on Medical Device Reporting (MDR) for Manufacturers. The goal of the guidance, says FDA, is...
Jan 11 2017,
How Often Should You Audit Your Suppliers?
EduQuest, a global team of FDA compliance experts, answers industry’s pressing questions. In this round, the experts offer Supplier Auditing...
Jan 10 2017,
A Watchful Eye on Device Performance can Decrease Postmarket Surveillance Burdens
Our global industry requires companies to develop harmonized postmarket surveillance systems that minimize inconsistencies in our understanding of product lifecycle...
Jan 10 2017,
One Answer to Your Postmarket Challenge: Planning
Planning goes a long way in moving from premarket to postmarket data collection. Vicki Anastasi, an OMTEC 2016 speaker, suggests...
Dec 07 2016,