Avoiding FDA Enforcement Actions: Understanding Quality Systems
The greatest challenge faced is an understanding of the intent of the written regulations and applying them correctly.
Tag Archives: design controls
Why You Must Have a Single Source of Truth for CAPA
CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.
Quality Considerations for Drug-Device Combination Products
Understanding the GMP requirements of each component is critical to product and compliance success.
Engineers: How to Curb Quality Myths Now
The most successful medical device companies have the same characteristic in common: They’re cross-functional. Whether it be the device design and development activities or quality and regulatory affairs, every operation works together to produce and market medical devices that improve patients’ lives.
4 Keys to Funding Your Medical Device
How will you make your company more attractive to investors?
What, No Risk Analysis?
Procedures for design validation must address risk analysis where appropriate.
The FDA and Risk, It Matters
Is your risk management process rock solid?
Significant Design Change Requires FDA Notification
Adulterated product and QSR compliance issues create the perfect storm for a warning letter.
4 Reasons Your Risk Management Approach is Wrong
Risk Management is the single most important topic impacting the medical device industry today.
Account for Quality Across Product Design
Much of this involves communicating with your customer, and doing it often.
