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
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...
Managing a Software Bill of Materials (SBOM)
The FDA's heightened cybersecurity standards, implemented in October 2023, have changed submission requirements for medical devices. In this blog post, we'll explore the key updates and detail key information about effective Bill of Materials (BOM) management,...
Design Controls Best Practices for Medical Device Companies
Ensuring regulatory compliance and fostering trust in products are paramount for medical device manufacturers. The FDA, European Competent Authority, and Health Canada closely oversee design, development, and manufacturing for patient safety and efficacy....
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...
MasterControl’s Quality Management Software: Navigating Compliance with Confidence
Looking for a great out-of-the-box solution for a Quality Management Systems (QMS) that exceeds the compliance requirements for FDA? MasterControl could be a good option for you. It even includes the stringent guidelines outlined in 21 CFR Part 820. Let’s take a...
Emerging Trends in Risk Management for 2024
There is a paramount importance to staying ahead of new risks. After all, more and more crop up each day as technology and processes change. So, in this blog post we’re exploring the 2024 trends for risk management.Why Manage Risk? It sounds like a simple question...
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The personalized attention and detailed communication we receive working with SPK and Associates is pretty special. The accessibility of SPK team members is impressive.
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Director, Active Device Research and Development, BBraun Medical Inc.
