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
Navigating Tariffs: How SPK’s Expertise Can Lead to Enhanced Automation in U.S. Medical Device Manufacturing
Tariffs have long been a tool of economic strategy, but recent escalations are impacting U.S. manufacturers, especially in the medical device industry. From 10% baseline tariffs to 245% duties on Chinese imports, companies now face inflated costs and disrupted global...
How SPK’s Application Management Services Optimized Licensing Costs and Enhanced Tool Utilization
Licensing costs can be expensive, especially when you have large teams utilizing multiple tools. In the case of one of our clients, a medical equipment supplier, they were spending thousands of dollars on dozens of tools. Luckily, with the help of SPK as their...
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
Developing high-quality products quickly can be a challenge without the proper tools, processes, and partners to help. Dive into this eBook to discover how partnering with SPK can help you achieve product development success.What You Will Learn In this eBook, we will...
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...
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.