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...
Cybersecurity
Modern Medical Device Design in the IoT Era
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...
Cyber Security in Medical Device Design
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...
PLM in the Cloud: Computer System Validation in FDA Regulated Industries
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...
How to Install Snort on a Redhat 6 Box
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...
Blog: Leveraging PTC’s Integrity Platform for IEC 62304 Compliance
SPK and Associates leverage PTC’s Integrity platform to help Medical Device companies develop software efficiently while achieving IEC 62304 compliance.
Using SSH to Securely Tunnel a TCP Application
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 Password Database Leaked!
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...
A Review of FDA 483 Observations – Top Med Device Issues Sited & Proper Response
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.
CAPA: A Review of 21 C.F.R. §820.100 and FDA Warning Letter Trends
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...
Security layers on a modern website
Last time, we looked at a basic website design. Now it’s time to start digging into the details around what’s really being used behind the scenes. This time, we’ll focus on security aspects. When a user starts their browser and connects...
Enterprise Storage – Do you really get what you pay for?
In my last blog post, I touched on my experience with Network Appliance filers and remote server monitoring. This week, I will be discussing alternative storage solutions, and how they measure up to one of the biggest players in the Network Attached Storage...