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Compliance & Regulatory

Codebeamer’s Role in Ensuring DO-178C Compliance

Codebeamer’s Role in Ensuring DO-178C Compliance

Ensuring avionics software is reliable and safe is a top priority for aviation engineers. However, maintaining compliance throughout the software lifecycle is no simple task. Utilizing an ALM tool such as PTC’s Codebeamer can help ensure compliance with aviation...

15 Data Questions Executives Need to Ask

15 Data Questions Executives Need to Ask

The ability of executives to harness insights from data is crucial for driving strategic decision-making and maintaining competitive advantage.  In our data advisory engagements, we are often helping teams and executives better understand their data. Through those...

A Detailed Comparison of PTC Windchill and Siemens Teamcenter

A Detailed Comparison of PTC Windchill and Siemens Teamcenter

Two of the most common enterprise PLM software on the market are PTC Windchill and Siemens Teamcenter  These product lifecycle management solutions have many similarities, but there are a few key differences that may be deciding factors in choosing one. At SPK, we...

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...