The difference between quality assurance (QA) and testing is often misunderstood. In fact, the terms are frequently used interchangeably. However, testing is actually just one part of QA. Quality assurance, on the other hand, covers a larger, more holistic part of the...
Requirements/Test Management
The Purpose of Unit Testing (Updated 2023)
At SPK, we specialize in supporting companies to accelerate their product development. And, one key aspect of that is redefining the role of unit testing in the development process. Essentially, the way you approach testing can greatly impact the success of your...
Insights from Greenlight Guru’s 2023 MedTech Industry Benchmark Report
In a year of unexpected twists, the medical technology (MedTech) industry finds itself amidst shifting sands. So, Greenlight Guru’s 2023 MedTech Industry Benchmark Report is a treasure trove of insights into MedTech trends and the landscape. Let's deep dive into some...
Best Practices for Successful eQMS Implementation
Are you a medical device manufacturer seeking to overcome the challenges of your current quality management? Let me help you show you the light. In this blog, we will show you the advantages of adopting an Enterprise Quality Management System (eQMS). Better yet, one...
Metrics to Improve DevOps Performance
Metrics to Improve DevOps Performance DevOps has revolutionized the way organizations deliver high-quality applications. By seamlessly integrating software development and IT operations, DevOps drives efficiency and collaboration. However, to unlock the true potential...
Codebeamer: Agile ALM For ISO 26262 Standard
Meeting safety standards for road vehicles demands a systematic approach. And this is exactly what is needed to comply with ISO 26262 standard (the road safety standard). Agile's flexibility and rapid iteration may not suffice for ISO 26262. But, Creating Agile ALM...
What You Should Know And Do After Migrating To Atlassian Cloud
If you’re reading this blog, the chances are you’ve either followed the right cloud migration tips and successfully migrated to the cloud. Or, you’re en route to a cloud migration and wondering “but what next?”. There are plenty of articles available on the web that...
Leveraging PTC Integrity for IEC 62304 Compliance
Executive Summary Our medical device customers report that up to 70% of new product innovation is being created in the software domain. This represents an increase in both volume and complexity. In this white paper, you'll learn: The 3 different use cases explained A...
PTC Integrity (RV&S) — Test Management Demo
A Demonstration of PTC Integrity’s Test Management functionality – By Jim Winder
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...
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 &...
Risk Management in Windchill RV&S (formerly PTC Integrity Lifecycle Manager)
An important part of creating any product intended for use in any regulated industry vertical is that the manufacturer should have identified all of the risks involved in using the device. Then, they must have done their best to mitigate those risks before their...