I'm a huge fan of automation, especially when it comes to installing software. With a simple one-click solution, you can setup software on a user's workstation with little or no impact on your work load. In fact, you don't even need to do the installation -- users can...
SPK and Associates leverage PTC’s Integrity platform to help Medical Device companies develop software efficiently while achieving IEC 62304 compliance.
Occasionally I’ll get a comment from a potential client who is particularly price sensitive about the rates for our consultants, and the comment usually goes something like: “I can hire a full-time employee who would cost me a lot less than what you are going to...
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...
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...
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 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...
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...
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...
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...
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 &...
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...