Security in the 21st century is a complicated game. The good guys are always playing catch up with the bad guys. Security is particularly important for medtech companies due to their specific compliance needs. Banking and fintech likewise have a high bar for security...
Requirements management isn’t optional in many fields. Medical technology and finance are just two fields where regulatory compliance necessitates requirements management. You and other stakeholders simply must be in total agreement about the requirements of a given...
By the end of this white paper you will be well informed regarding the advantages and setbacks of IoT solutions for medical device product development. The use of IoT in Medical Devices is a complex and highly relevant topic. This white paper will: Explore intelligent...
In our last article we talked about the four steps your organization must go through when designing secure connected medical devices. With the increasing attention paid to product security in this era of connected medical devices, many companies are scrambling to keep...
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.
Medical Device manufacturers regulated by the FDA are subject to cGMP (Current Good Manufacturing Practice) regulations and may be inspected by the FDA to ensure compliance. If the FDA inspector(s) observes conditions that in their judgment may constitute violations,...