It’s Basic Blocking & Tackling
An FDA inspection should never be confused with a notified body audit.
Tag Archives: quality
Quality Matters: Do It Right the First Time
Entering the Japanese device market requires an excellent regulatory team.
Statistical Techniques: Zero for 11
Every company should understand the value of employing statistics to assist in running a business.
Steady Improvements to Medical Device Quality in China
How CFDA enforces new regulations is critical to the future.
Ready, Set, Action: Correction, Preventive or Corrective?
Having a grasp on which actions are necessary at various stages of the CAPA process is critical to a quality program.
Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing
Why regulatory and quality due-diligence is often overlooked.
Combination Products to Get Part of $5.1 Billion Requested FDA Budget
The agency is creating a virtual center of excellence to expedite the development of combination products.
Fail to Respond to Form 483 Observations and Win a Warning Letter
A monumental screw up, complete with bad quality, regulatory and statutory practices.
Medical Device Software Safety, Quality, and Compliance: What Really Makes A Difference?
A look into the importance of high-quality software in the medical device industry.
Account for Quality Across Product Design
Much of this involves communicating with your customer, and doing it often.
