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Compliance & Regulatory

Streamlining Design Controls For A Leading Medical Device Maker

Streamlining Design Controls For A Leading Medical Device Maker

SPK helps this global enterprise to boost product development efficiencies, increase compliance reliability, generate reports with a single click, and shave weeks off their development/release cycles. The Client A respected global medical device powerhouse, with more...

How Hybrid Cloud Can Turbo Charge Your Manufacturing Enterprise

How Hybrid Cloud Can Turbo Charge Your Manufacturing Enterprise

Executive Summary That’s the year public and private cloud-based solutions are set to surpass traditional data centers in terms of overall spending. In 2017, nearly two thirds of spending went toward private cloud solutions. Cloud usage exploded in 2017, to the tune...

Problems that Engineers in Regulated Industries Face

Problems that Engineers in Regulated Industries Face

https://www.youtube.com/watch?v=Og6826J7EOo Video Transcript: I'm Carlos Almeida, VP of Engineering at SPK and Associates. I've spent most of my professional life doing software engineering. 25 years plus in the world of high tech in the electronic design automation...

Test Management in Windchill RV&S (PTC Integrity)

Test Management in Windchill RV&S (PTC Integrity)

The importance of test management, especially in highly-regulated industries, cannot be overstated. Efficient management of testing requirements leads to safer products, effective production, and satisfied customers. The PTC Windchill Requirements Validation &...

What’s in the MITRE/FDA Playbook?

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...

How Cyber Security Requirements Can Throw your Medical Device Off Track

How Cyber Security Requirements Can Throw your Medical Device Off Track

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...