Requirements Management
Requirements and traceability for medical device, aerospace, automotive industries.
Requirements management is arguably most important for medical device, aerospace, and automotive industries because managing their product incorrectly could mean life or death. The factors of safety, reliability, security, quality and traceability are paramount and what drives the success of companies in these spaces.
With SPK’s over 20 years of experience, we bring a unique and proven track record to help clients in these industries. Whether it’s IEC 62304, AS9100, or AATF 16949, our team has the experience and experts to help support requirements management tools and processes that are fully compliant and help get your product to market faster.
How SPK Helps with Requirements Management
Because of the increasing regulations and industry compliance required for medical devices, aerospace and automotive industries, SPK’s clients are more regularly looking for solutions based on existing technology which has already been proven to work and comply with all the desired protocols. This includes many different compliant tools, processes with technical components and other innovations.
Leaders in these industries must look to optimize the quality of their products by closely synchronizing their hardware and software teams. If these teams can work together well, and within the requirements of the tools they are using, their workflow is more conducive to success and time to market is maximized. SPK works diligently with our clients to ensure they know the places they can reduce risk or wait times while still being compliant. Minimizing wasted time by using software integrations, technology automations and best practices is the key to success. Whether you’re in need of a new or updated PLM system or trying to validate an existing platform for your requirements management, SPK has experience to support your needs.
Recent Requirements Management Resources
A Guide to Calculating the ROI of Application Lifecycle Management Tools
Modern organizations need the latest solutions to keep up with competitors. Explore how integrated ALM tools like Codebeamer can lead to greater ROI.What You Will Learn In this eBook, you will learn: The technical benefits of ALM How to calculate the ROI of your ALM...
Top Test Management Tools Every Software Team Should Know
Modern software teams may be faster than ever, but they can only release with confidence if they have strong testing practices in place. As distributed teams, hybrid QA models, and rapid DevOps cycles increase, test management tools have become the backbone of...
Modernizing Life Sciences: Unlocking Value Through Digital Transformation
Biopharma and medtech leaders are under constant pressure to accelerate clinical development and satisfy increasingly demanding regulators. Digital transformation is the way to do this. This doesn’t just mean adopting new tools, but rather rethinking how science,...
Simplifying Enterprise Tool Modernization Without the Headaches
Migrating from legacy systems to modern platforms doesn’t have to be painful. Yet for many enterprises, moving from tools like Rally, HP ALM, or IBM DOORS to platforms such as Jira or Codebeamer often feels risky and complex. In this webinar, Michael Roberts, Vice...
Potential Impact of Tariffs on the Medical Device Industry
As the medical device industry continues to innovate at breakneck speed, it now faces a new headwind: sweeping tariffs introduced in 2025 by the U.S. government and mirrored by key global trade partners. These changes are creating a ripple effect across the global...
Strategic Approaches to Hospital Medical Equipment Installation
Successful medical equipment installation in hospitals requires continuous stakeholder engagement, infrastructure readiness, testing and training, and continued maintenance. When done properly, staff can quickly and easily use the devices, directly elevating patient...
What Our Clients Say
SPK has been an invaluable partner in transforming our software development process. With SPK's guidance, our team embraced efficient methodologies and cutting-edge tools, significantly improving our development cycle and product quality.
Joshua Talbert
CEO, mysherpas
Working with SPK feels like working with co-workers in my company, not like interacting with a typical technical support vendor. SPK staff are responsive and partner with me.
Jay DiToro
Director of Systems & Technology, Veranex
The personalized attention and detailed communication we receive working with SPK and Associates is pretty special. The accessibility of SPK team members is impressive.
Evan Bruck
Director, Active Device Research and Development, BBraun Medical Inc.