The greatest challenge faced is an understanding of the intent of the written regulations and applying them correctly.
CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.
Understanding the GMP requirements of each component is critical to product and compliance success.
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.
How will you make your company more attractive to investors?
Procedures for design validation must address risk analysis where appropriate.
Is your risk management process rock solid?
Adulterated product and QSR compliance issues create the perfect storm for a warning letter.
Risk Management is the single most important topic impacting the medical device industry today.
Much of this involves communicating with your customer, and doing it often.