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When it comes to the Internet of Things (IoT) and connectivity, embedded software security is a top concern for a growing number of manufacturing companies and their software engineers. The worldwide market for embedded security software is forecasted to rise to $2.95...
In my most recent blog articles, I discussed a few aspects an organization might want to consider when looking at a cloud-based solution. Security is one of the top issues on the list. Regardless of whether your application consists of highly sensitive patient data...
In the past, medical device design focused on a standalone unit or a group of a couple devices that worked together. While that was a great idea, the number of compatibility issues that could occur also blocked connectivity to other devices. With the stream of new...
With the push by big technology players (Cisco, Google, Intel, etc.) towards connectivity in everyday devices, cyber security is becoming more and more crucial. This push is even seen in medical device design as the industry begins to move toward cloud-integrated and...
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...
Snort is used for performing security checks on network boundaries. This can be done on the outside Untrust network but is sometimes more useful to look at what’s getting through your firewall into the web servers. Follow our step-by-step instructions on how...
SPK and Associates leverage PTC’s Integrity platform to help Medical Device companies develop software efficiently while achieving IEC 62304 compliance.
Often times, I'm caught in a situation where an application or service is not directly accessible to me from the network I'm currently on. For instance, if I'm at a customer site, I may need VNC or RDP access to a collocated server. Sure, I could open up port 5901...
LinkedIn, the social network for professionals, has reported that its user database has been hacked and the encrypted passwords of 6+ million users have been stolen. Even though the password database was encrypted, users with weak passwords could be exposed with...
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.
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...