Resources to Help Accelerate Your Product Development
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Medical Device Compliance: Deciphering the Variances Between MDD and MDR
Back in 1993, the concept of IoT, fitness tracking apps or computerized surgical equipment sounded like something of Star Trek. But in 2023, tech is everywhere - and our medical devices have evolved for the better due to this. However, with evolution, also comes the...
Accelerate Your Software Development Process: How GitLab DevSecOps Boosts Efficiency
At SPK and Associates, our aim is to help you deliver your product to market faster than ever and with enhanced quality. That means helping you to align with the best tools in the industry so you can tap into more growth. Additionally, we have partnered with GitLab to...
Why Microsoft Azure is the Manufacturing Industry’s Trusted Partner
As the manufacturing industry continues its evolution, the choices we make today can shape the future of our operations. At SPK and Associates we’ve seen this happen repeatedly with new clients either in sticky situations, or struggling to scale. Basically, technology...
Troubleshooting SolidWorks: Can’t open .STP files
Hi everyone, I am Daniela, the SolidWorks PDM SME for SPK and Associates. Today, I’ll be sharing a helpful guide for troubleshooting SolidWorks .STP files and importing a STP (referred to as "STEP" files) assembly as SolidWorks parts. This technique has proven...
Emerging Trends in Risk Management for 2024
There is a paramount importance to staying ahead of new risks. After all, more and more crop up each day as technology and processes change. So, in this blog post we’re exploring the 2024 trends for risk management.Why Manage Risk? It sounds like a simple question...
4 Advantages of SolidWorks Cloud PDM (Updated 2023)
Considering the leap to cloud-based CAD and PDM solutions? A move to platforms like SolidWorks 3D CAD in the cloud paves the way for unmatched flexibility. Imagine accessing intricate engineering data from anywhere at any time. And, the benefits don’t end there. In...
DevOps as a Service Supercharges Development Pipelines
It seems like just about every company is now a part-time or full-time software company. But, for small and mid sized companies, employing effective practices, such as DevOps to manage the day-to-day, might not be feasible. However, there is a solution. It’s called...
The Power of Trend Analysis in Drug Development with eQMS Platforms
There is an intrinsic value of identifying trends in data for medtech manufacturers. Yes, the prospect of avoiding scrutiny from federal auditors is a tangible benefit. However, the true motivation for proactive medical device trend analysis lies in its power to...
How To Improve Your Google Workspace Security
At SPK and Associates, we are dedicated cybersecurity partners for small and medium businesses (SMBs) worldwide, understanding their unique challenges. Google Workspace, a cloud-based suite by Google, is invaluable for SMBs due to its cost-effective subscriptions,...
The Trio of Documentation: DHF, DMR, and DHR in Medical Device Manufacturing
The FDA plays a pivotal role, setting the gold standard for regulatory oversight. Manufacturers must meticulously adhere to FDA regulations, such as the Quality System Regulation (QSR) under 21 CFR Part 820, governing key aspects like design controls, production...
Latest White Papers
Six Trends That Are Shaping Supply Chain Transformation for Manufacturers
In the modern era of innovative technology, many manufacturers are looking for new ways to prevent supply chain disruption. One of the best solutions is to adopt cloud-based applications to gain real-time insights into supply chains. This is known as supply chain...