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Medical Device Engineering

How To Complete Computer Systems Validation (FDA)

How To Complete Computer Systems Validation (FDA)

What is Computer Systems Validation (CSV)? Additionally, why does the Food & Drug Administration (FDA) require them for the Medical Device industry? More importantly, how can CSVs be efficiently completed and managed? Let’s explore why you can’t skip that...

Why Process Automation Is Critical For Engineering

Why Process Automation Is Critical For Engineering

Process automation releases your engineers for the work their brains are intended for. That work is creativity and problem-solving.  By implementing process automation, you improve the team’s morale. Firstly, they get more focus time for deep work and designing better...

Single Pane of Glass Dashboards: What are they?

Single Pane of Glass Dashboards: What are they?

There’s simply too much information.  We all know this.  So how can the “single pane of glass” (SPOG) dashboard simplify quantitative data? And why is data driven analytics of interest to companies? Every day, more data arrives in our inbox – text messages, reports,...

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...

Accelerating Product Development with Engineering Operations

Accelerating Product Development with Engineering Operations

What is Engineering Operations (EngOps)? Why do you need it, and how do you effectively deploy it?There’s a strange interplay between IT and engineering teams in most firms. That’s because the tech stack that engineers need to design, build, test, and release products...

Accelerating Product Releases with Business Process Automation

Accelerating Product Releases with Business Process Automation

The beauty of business process automation How often have we entered the same information into two different systems and wondered, “Why do I have to waste my time doing this?”  These are computers, aren’t they?  Shouldn’t this information flow where it needs...

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 &...