Product Lifecycle Management (PLM) plays an important role in the manufacturing industry. Ensuring all factors of a product are well-documented is a priority for every business. Keeping this information organized is not just a good business practice, but it...
The automotive industry is one of the largest industries in the world. The market is projected to grow to 2.95 trillion U.S. dollars this past year, causing a substantial amount of disruption. With this immense scale, comes many requirements manufacturers must follow....
ISO standard 9001:2015 refers to the regulatory requirements companies must abide by when managing the quality of their product(s). The main goals of ISO 9001 are customer satisfaction and product improvement. There are a few main things that must be defined when...
Ensuring medical device quality is critical. So, you’ll need to understand and meet ISO requirements to appeal to potential buyers and streamline management. In this blog, we discuss ISO 9001 as it relates to medical device manufacturing, what your business can do to...
It's good practice to observe the regulations a software solution conforms to before choosing one for your business. In this blog post, we will be exploring the updates Atlassian Cloud has added to its regulatory compliance guidelines in recent years.Atlassian Cloud...
As autonomous technology outpaces regulatory standards, further focus is needed to ensure the safety of self-driving vehicles. SPK and Associates, in collaboration with PTC SOTIF ISO/PAS 21448, brings you an insightful guide - a comprehensive eBook on the Safety of...
ALM tooling, when implemented correctly, can support automotive software engineering, Agile transformation journeys and linking requirements to business strategy, encouraging collaboration. Additionally, it can be helpful for providing an overview of QA and testing...
This free eBook helps you navigate automotive software development, spanning over a century of evolution, from the Ford Model T to contemporary electric vehicles with embedded systems. Together with PTC, we’re sharing this eBook to highlight the complexities of modern...
Navigating the complexities of ISO 14971:2019 can be challenging. But, with this eBook presented by SPK and Associates and PTC, you're taking the first step towards expertise in medical device compliance. What's In The ISO 14971:2019 eBook This comprehensive guide...
Are you navigating the complex terrain of automotive development? In an industry where the lines of code have surged from 10 million to a staggering 100 million in the last decade, ensuring functional safety has become paramount. And, as the automotive landscape...
In this Vlog, Chris McHale, Co-founder, and CEO of SPK and Associates is joined by Carlos Almeida, Vice President of Engineering. Together, they’re discussing FDA compliance and the recent shifts impacting medical device companies. Topics for discussion include...
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...
