SPK and Associates leverage PTC’s Integrity platform to help Medical Device companies develop software efficiently while achieving IEC 62304 compliance.
Cybersecurity
Why Fortune 1000 Companies Trust SPK’s SOC 2-Certified Cloud Hosting Services
The need for secure data storage and management is paramount in the modern business landscape. This is especially true when working within or migrating to a cloud-hosted environment. Partnering with a SOC 2-compliant cloud hosting vendor like SPK, means your sensitive...
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...
The Ultimate Jira Data Protection
Remote work is here to stay, and companies are turning to cloud-based solutions to support their teams. Atlassian's suite of products is a top choice for businesses worldwide. But, many businesses are still unsure about its built-in data protection capabilities....
Enhance Your App’s Resilience with GitLab Dynamic Application Security Testing (DAST)
As cyber threats become more sophisticated, so must our approach to securing applications during development. In this blog post, we'll explore the significance of Dynamic Application Security Testing (DAST) and how integrating GitLab's DAST into your development...
Podcast Series: Can IoT Jump These Five Hurdles? – Episode 1: Introduction
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Bitdefender Antivirus In AWS – Top Five Advantages
Today, modern security tools including Bitdefender antivirus are known as EDR solutions (Endpoint Detection and Response). They are the next evolution of anti-virus software. Anti-virus software has always operated based on a “database” of malicious software...
9 Things You Need To Know About Cybersecurity and Protected Health Information (PHI) breaches
In the past 18 months, there have been breaches of security related to protected health information (PHI) at Broward Health, Florida Healthy Kids, and the Accellion FTA Hack. In turn, these breaches resulted in 11 more healthcare organizations getting exploited. ...
Four Steps to Securing Your Company’s Medical Devices
Connected medical devices offer enormous opportunity for manufacturers and consumers alike. They also carry the burden of increased risk due to cybersecurity flaws. Think about the dangers of having your email or bank account hacked. Now consider the damage hacking a...
