One of the major points of pain in any development process is how do you prove that the product you’ve built for the marketplace actually does everything you want it to do. The simple answer of course is “Why you test it to make sure.” But the simple answer isn’t...
Traditional medical devices are quickly going the way of the ear horn for one simple reason: their valuable data is confined to the device. Some have short-term storage capabilities. None, however, capture data over time for long-term analytics or storage. Intelligent...
The Internet of Things is revolutionizing the medical device field. However, it’s also introducing new compliance headaches. What’s more, large-scale medical hacks loom large in the background. Medical device manufacturers can’t ignore the Internet of Things, but nor...
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.