Advanced CAPA Conference Digs Deep into Challenges and Root Cause Analysis
This educational event will help medtech manufacturers learn about one of the most complicated aspects of quality system requirements.
Tag Archives: quality
Best of 2018 in MedTech
Here are the most read articles of the year.
Supplier Quality Considerations For Quality and Regulatory Service Providers
When outsourcing these key functions, asking the right questions will help minimize the risk.
EU MDR Supplier Quality Requirements: Convergence of Best Practice and Regulation
With the heightened supplier scrutiny, it’s time to reevaluate your supplier quality program.
Why Is Quality Focusing on Compliance?
Excessive focus on compliance can create hurdles in cultivating quality and innovation.
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.
