1-888-310-4540 (main) / 1-888-707-6150 (support) info@spkaa.com
Select Page

Medical Device Engineering

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

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 to go? ...

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...