Why Is Quality Focusing on Compliance?
Excessive focus on compliance can create hurdles in cultivating quality and innovation.
Tag Archives: quality
CDRH Launches Manufacturing and Product Quality Pilot Program
The program intends to promote quality in medical device design and manufacturing.
The Ultimate QA/RA Cheat Sheet
It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
It’s Basic Blocking & Tackling
An FDA inspection should never be confused with a notified body audit.
Quality Matters: Do It Right the First Time
Entering the Japanese device market requires an excellent regulatory team.
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.
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.
