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.
Internet of Things (IoT)
Podcast: Can IoT Jump These Five Hurdles? Episode 4 – TCO and ROI
In the fourth episode of our podcast series “Can IoT Jump These Five Hurdles?”, SPK & Associates’ Chief Strategy Officer, Rajiv Mistry, explains the challenges of IoT total cost of ownership and return on investment. To see all published episodes, scroll down this...
Latest AWS News for Q3 2022
With over 1100 product and service updates from AWS in 2022 alone, you may have missed some of the more important notifications from the cloud services giant. Luckily, SPK’s team is here to provide you with a summary of the latest and greatest from Amazon Web...
Podcast Series: Can IoT Jump These Five Hurdles? – Episode 1: Introduction
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Back to the Basics of IoT
Consumers have taken a vanguard role in pushing innovation. IoT is changing the face of data collection, analytics and transmission. The field continues to evolve as new applications for smart devices develop. Download this white paper to learn more about how the...
Protecting Device Storage Using Windows UWF
The Unified Write Filter (UWF) is a Windows native feature that ensures a system’s data remains as an unmodified, secure baseline. Data can be changed by a Windows UWF system user. However, the changes do not persist after a restart. In fact, changes are discarded...
What Is A Digital Twin And Why Is It Important?
Manufacturing companies, even the ones that are not highly regulated, have no shortage of complexity these days as they build, scale and manage multiple interdependent pieces of equipment, software bundles and networks. All this, while under time and cost pressures....
Helping a Company Achieve Financial Regulatory Compliance Out Of The Box
One SPK financial industry client found it needed to overcome complex cybersecurity compliance demands imposed by the Financial Industry Regulatory Authority and the Securities Exchange Commission. To comply involved automatically collecting data about any...
What’s in the MITRE/FDA Playbook?
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...
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...
Multi-Cloud Is the Future of Infrastructure… For Now
Does this sound familiar? Your organization has settled into its cloud migration. You’re enjoying the increased security and resiliency. You feel like you’ve just climbed a mountain and you want to spend some time gazing out from the summit. Then you read about...
Podcast: Hybrid Cloud and the Industrial IoT Can Up Your SMB’s R&D Game
For small and medium-sized businesses in the manufacturing industry, hybrid cloud allows for quick and easy integration of what you already have deployed. You also have easier access to new processes, such as the Industrial Internet of Things. This emerging technology...
