The new European Regulation related to medical devices – as adopted by the European Union (EU) Council on 5 April 2017 – does not provide 3D printing with a specific status, raising questions regarding the regulations applicable to this medical innovation.
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).