Every company should understand the value of employing statistics to assist in running a business.
Failure to provide records during an inspection will undoubtedly lead to a warning letter.
Storing gasoline next to orthopedic trays and instrument trays just isn’t a good idea.
Device establishments should be able to read and comprehend 21 CFR Part 807.
Comply all the time, not just when FDA announces an inspection.
You must have established procedures for complaint management and MDRs.
Production and operations managers—make sure your preventative maintenance procedures are up to snuff.
The Quality System Regulation (QSR), for production and process controls, (21 CFR, Part 820 – Subpart G, Section 820.70) is in the opinion of Dr. D one of the more salient requirements of the regulation.
The identification and traceability (sections 820.60 and 820.65) for products and finished medical devices, throughout the entire manufacturing process, including raw materials employed during the manufacturing process, and the subsequent sale and distribution of medical devices, are critical elements of the Quality System Regulation (QSR).
FDA is really taking medical device manufacturers to task in regards to purchasing controls and the overall management of their suppliers. According to Kimberly Trautman, FDA’s current Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR) expert, suppliers providing non-conforming material are directly related to an increase in medical device recalls; which increases the need for effective quality processes to mitigate risk. As the medical device industry continues to grow in leaps and…