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...
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...
You need more than just an antivirus and security suite to keep your system safe. You need multiple, non-redundant solutions covering various aspects of network security. In our last blog, we discussed the role of whitelisting in keeping your network secure. Now we’re...
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...
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...
In episode five of our podcast series "Can IoT Jump These Five Hurdles?", SPK's Director of Strategy, Rajiv Mistry, discusses systems standards and regulation challenges that could impede IoT's future growth and effectiveness. Think VCR v.s. Betamax or Blu-Ray v.s....
In the second episode of our podcast series "Can IoT Jump These Five Hurdles?", we transition from a broad introduction of these five hurdles to a deeper dive into each challenge facing the Internet of Things. Let's begin with the smart device itself and it's digital...
An important part of creating any product intended for use in the medical field is that the manufacturer should have identified all of the risks involved in using the device, and have done their best to mitigate those risks before their product ever sees a patient....
The value system and practices that embody Agile Software Development have been around for well over a decade, and have been touted as having "crossed the chasm" by organizations such as the Agile Alliance, Gartner, and Forrester Research. Numerous studies indicate...
Whether or not your in a heavily regulated industry, having a solid email archiving solution is an absolute necessity. Email’s importance in the workplace for the past decade-and-a-half is similar to the need of having a dial tone in years past. In addition, email is...
Product lifecycle management (PLM) systems have evolved from being custom-built, on-premise applications to cloud-based, off-the-shelf solutions. As adoption for PLM in the cloud increases, system validation approaches in FDA/GXP regulated industries have had to...