NMPA published the “Guideline for On-Site Inspection of Medical Device Supplier Quality Management (Draft)” on June 27, 2024. Feedback needs to be submitted by...
Keonne Rodriguez and William Lonergan Hill, the founders of Samourai Wallet, have been detained by the U.S. Department of Justice for allegedly laundering over...
This article highlights some of the similarities and differences between the Medical Device 510(k) and CE Marking regulatory pathways and helps harmonise some aspects...
All domestic and overseas manufacturers with approved medical devices shall conduct the annual self-inspection of the quality management system, according to Decree 719 “Medical...
Alister Milne is a well-known figure in the cryptocurrency and blockchain community, primarily recognized for his role as an investor and entrepreneur. Milne is...
Complaints handling mistakes, medical device reporting, and CAPA are the most common reasons for FDA 483 inspection observations, but why?
Reasons for FDA 483s related...
