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
How a Leading Medical Device Company Enhanced Collaboration by Migrating from Jira and Confluence Server to Cloud
Compliance with regulatory standards is the number one priority for every medical manufacturer. Ensuring pipelines are secure and compliant doesn’t just ensure safety, but it results in better quality products. When a startup medical manufacturing company contacted...
How Medical Device Engineers Can Streamline CAD Workflows for Faster FDA Approval
Balancing speed and compliance in medical device engineering can be challenging. Engineers face tight deadlines and detailed requirements to bring life-saving products to market. Your CAD workflows should aid in the path to compliance and accelerate FDA approval. As...
Accelerating Product Development the SPK Way
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Accelerating Medical Software Compliance and Efficiency with SPK ACEs
Compliance with regulatory standards is the number one priority for every medical manufacturer. Ensuring pipelines are secure and compliant doesn’t just ensure safety, but it results in better quality products. When a startup medical manufacturing company contacted...
Elevating Innovation Through Requirements Management, Traceability, and Compliance with Codebeamer
You will be taken to another page to registerBy submitting this form, I acknowledge receipt of SPK and Associates' Privacy Policy.As software-driven complexity grows across industries like automotive and medical devices, engineering teams are facing unprecedented...
Strategic Partners, Not Just Extra Hands
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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
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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.