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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

Shifting from FDA 21 CFR Part 820 to ISO 13485

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...

Design Controls Best Practices for Medical Device Companies

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....

Introduction to ISO 14971:2019 for Medical Device Compliance

Introduction to ISO 14971:2019 for Medical Device Compliance

Navigating the complexities of ISO 14971:2019 can be challenging. But, with this eBook presented by SPK and Associates and PTC, you're taking the first step towards expertise in medical device compliance. What's In The ISO 14971:2019 eBook This comprehensive guide...

Emerging Trends in Risk Management for 2024

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...

Companies that Trust SPK and Associates

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.