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Medical Device Engineering

Smarter Engineering For Medical Devices

Smarter Engineering For Medical Devices

Medical devices are subject to some of the strictest design control regulations in the world. And for good reason. U.S. medical devices are governed by the Food and Drug Administration (FDA). In order to meet the high standards, teams must communicate - effectively....

SPK Accelerates Fortune 100 MedDevice Product Sale

SPK Accelerates Fortune 100 MedDevice Product Sale

Our client is Fortune 100 Medical Device manufacturer. SPKAA acts as a product cybersecurity managed service provider for their hospital products which have embedded Windows or Windows OS.   Fortune 100 MedDevice Problem For over 10 years, SPK has provided ongoing...

2022 Guide: Software as a Medical Device (SaMD)

2022 Guide: Software as a Medical Device (SaMD)

What is software as a medical device? Software as a medical device, or SaMD is software that is intended for one or more medical purposes. This software performs those purposes without being part of a hardware medical device.  SaMD devices also need to meet the...

SPK and Associates Partners with Greenlight Guru

SPK and Associates Partners with Greenlight Guru

Accelerating Product Development to Improve Patient Outcomes SPK and Associates, a leading woman-owned technology consulting company, today announced its partnership with Greenlight Guru, pioneer of the only dedicated Medical Device Success Platform (MDSP) to...

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...