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
Keeping Pace with Medical Device Software Updates
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The Importance of ISO 17025 for Testing and Calibration Laboratories
Testing and calibration laboratories play a critical role in industries ranging from manufacturing and chemicals to healthcare and research. Their results often influence product safety, regulatory compliance, and customer trust. Organizations must ensure their...
Health and Safety Regulations: A Revenue Impact Analysis
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Round-the-Clock Safety: The Importance of 24×7 Medical Device Monitoring
Modern healthcare relies on connected medical devices, from infusion pumps and ventilators to wearable cardiac monitors. These devices deliver lifesaving functions, but can also introduce risk if they fail or become compromised. That is why continuous monitoring is a...
Optimizing Hospital Efficiency with On-Site Medical Device Support
Hospitals depend on medical devices every day to deliver safe, accurate, and timely care. From imaging systems and surgical tools to specialized recording platforms, the reliability of this equipment directly impacts patient outcomes and operational efficiency. When...
Steps to Implement an Effective CAPA Process in Your Organization
Corrective and Preventive Action (CAPA) is a cornerstone of quality management in regulated industries. The CAPA process is essential not only for addressing current issues but also for proactively preventing future ones. It’s systematic, closed-loop, risk-based, and...
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Director, Active Device Research and Development, BBraun Medical Inc.