Document Manufacturing Quality Management System 
CMTC Manufacturing Tech
JULY 25, 2024
The medical device manufacturing industry is full of regulations. Reduces the Risk of Product Defects As a QMS Standard, ISO 13485 was designed to help medical device manufacturers and equipment suppliers develop strong quality management systems from the ground up.
CMTC Manufacturing Tech
AUGUST 9, 2022
To truly succeed at regulatory compliance and become a player in national and international markets, organizations must invest in implementing leading quality, safety, and regulatory standards such as ISO 13485. It’s essential to understand the basics of the standard and how it applies to small and medium-sized manufacturers.
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Additive Manufacturing
NOVEMBER 11, 2022
Where 3D printing really thrives in this industry is for short volume, high accuracy parts, but that’s not to say there hasn’t been successful applications of serialized parts like GE’s fuel nozzle that went into manufacturing in 2015 and is still being manufactured in thousands-per-year quantities.
CMTC Manufacturing Tech
JULY 26, 2022
Producing high-quality products your customers can depend on is the best way to achieve customer satisfaction and drive sales for manufacturing organizations. However, it takes robust, efficient, and sustainable quality management to deliver premium products consistently. What are QMS documents?
Additive Manufacturing
OCTOBER 24, 2022
The medical device market has historically been one of the pioneer industries using additive manufacturing (AM) for production. In fact, according to FDA’s analysis of medical device clearances, additive manufacturing has been used in medical device production as early as 2008 (Ricles, L & Oh, S. RAPID, May 2014).
Additive Manufacturing
JANUARY 17, 2023
When new to medical device development and manufacturing one daunting aspect can be developing a Quality Management System (QMS). Many industries use QMS or similar principals, so why does it seem so much harder to apply them to medical device quality systems driven by regulations? Change Control).
ATS
JULY 10, 2024
Share Standard Operating Procedures are the bedrock on which modern manufacturing rests. Without them, each employee is free to perform their tasks as they wish, which is usually slower and reduces product quality. What are Standard Operating Procedures (SOPs) in manufacturing?
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