Examining Methods to Determine Sample Sizes
Consider use of the acceptance sampling approach or the six sigma acceptable error approach to determine a sample size using...
Dec 05 2017,
Regulations
Why a Well-Conceived Test Plan is Crucial to Efficient Product Development
The elements are derived from the biological, mechanical or clinical performance requirements of the device and regulatory requirements for performance...
Dec 05 2017,
Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies
While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA...
Dec 04 2017,
Understanding the Critical Differences Between Supplier Audit and Evaluations
Martin Browning from EduQuest provides insight on evaluations and audits: "All of us who conduct audits recognize that most of them...
Dec 04 2017,
UDI Direct Marking Guidance Finalized by FDA
FDA did not offer device companies new direction on methods to direct mark, as it would be difficult to account...
Nov 28 2017,
Your EU Medical Device Regulation Guide
Big changes are underway for the European market and how it regulates medical devices with the recent unveiling of the...
Oct 09 2017,
CAPA Notes from an FDA Inspection
Corrective and Preventive Actions or CAPA touches nearly every process in the Quality Management System (QMS). Read insight gained by...
Oct 04 2017,
Risk Assessments: How Often Should I Update Them?
Denise Dion from EduQuest provides advice on when to update your risk documentation...
Oct 03 2017,
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,
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,