Part 820 – QUALITY MANAGEMENT SYSTEM REGULATION (Draft) Table of Contents Subpart A – General Provisions 820.1 Scope of Application. 820.3 Terminology820.5 [Reserved]820.7 Built-in […]
From QSR to QMSR (Quality Management Regulation) FDA intends to harmonize and modernize its quality system regulations for medical devices.
When the author witnessed an FDA inspection at a certain listed company, the president of the company asked the following
What is good quality? ISO-9000 defines quality as “the degree to which a collection of inherent characteristics satisfy requirements” is
FDA Warning Letter on CSV/Part 11 The author has always argued that CSV and Part 11 in computer systems I
About EN ISO 14971:2019 In Japan, international standards such as ISO are incorporated into domestic standards as JIS (Japanese Industrial
The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) conducted an audit of
Is CSV implementation that important? The author receives daily requests from pharmaceutical companies, medical device companies, vendor companies, and others
Is ISO 13485 certification required? The author is often asked by medical device start-ups and others to provide support consultation
For quite some time, the medical device industry has debated whether records are or are not documents.In ISO 13485:2016, it
