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Compliance & Regulatory

The Role of PLM in Orchestrating the Product Digital Thread

The Role of PLM in Orchestrating the Product Digital Thread

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...

Driving Quality with ISO 9001 Compliance in the Automotive Industry

Driving Quality with ISO 9001 Compliance in the Automotive Industry

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 9001: Quality Management in Medical Device Manufacturing

ISO 9001: Quality Management in Medical Device Manufacturing

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...

SOTIF ISO/ PAS 21448 Guide eBook

SOTIF ISO/ PAS 21448 Guide eBook

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...

Excellence in Automotive Software Engineering eBook

Excellence in Automotive Software Engineering eBook

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...

Shifting from FDA 21 CFR Part 820 to ISO 13485

Shifting from FDA 21 CFR Part 820 to ISO 13485

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...

ISO 26262 Top 8 Blunders

ISO 26262 Top 8 Blunders

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...

Introduction to ISO 14971:2019 for Medical Device Compliance

Introduction to ISO 14971:2019 for Medical Device Compliance

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...

DevOps as a Service Supercharges Development Pipelines

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...

SBOM Compliance: Navigating the Regulatory Landscape

SBOM Compliance: Navigating the Regulatory Landscape

Recent events, such as the Log4Shell / Log4J vulnerability, underscore the importance of best practices for cybersecurity in software development. And, with increasing cyber attacks, it’s more important than ever that organizations can pre-empt and respond to emerging...