On October 2018, the MITRE Corporation and the Food and Drug Administration released their joint document, Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook. This is the new Bible for organizations designing and manufacturing connected...
SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends. One of the problem areas most often cited in company audits continue to be the CAPA system/program. This month we will take a look at some of the latest FDA...
Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
This article reviews what an FDA 483 Observation looks like, some of the more common issues flagged in medical device companies, and how to respond.