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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

Smarter Engineering For Medical Devices

Smarter Engineering For Medical Devices

Medical devices are subject to some of the strictest design control regulations in the world. And for good reason. U.S. medical devices are governed by the Food and Drug Administration (FDA). In order to meet the high standards, teams must communicate - effectively....

SPK Accelerates Fortune 100 MedDevice Product Sale

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Our client is Fortune 100 Medical Device manufacturer. SPKAA acts as a product cybersecurity managed service provider for their hospital products which have embedded Windows or Windows OS.   Fortune 100 MedDevice Problem For over 10 years, SPK has provided ongoing...

2022 Guide: Software as a Medical Device (SaMD)

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What is software as a medical device? Software as a medical device, or SaMD is software that is intended for one or more medical purposes. This software performs those purposes without being part of a hardware medical device.  SaMD devices also need to meet the...

SPK and Associates Partners with Greenlight Guru

SPK and Associates Partners with Greenlight Guru

Accelerating Product Development to Improve Patient Outcomes SPK and Associates, a leading woman-owned technology consulting company, today announced its partnership with Greenlight Guru, pioneer of the only dedicated Medical Device Success Platform (MDSP) to...

How To Complete Computer Systems Validation (FDA)

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What is Computer Systems Validation (CSV)? Additionally, why does the Food & Drug Administration (FDA) require them for the Medical Device industry? More importantly, how can CSVs be efficiently completed and managed? Let’s explore why you can’t skip that...

Why Process Automation Is Critical For Engineering

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Process automation releases your engineers for the work their brains are intended for. That work is creativity and problem-solving.  By implementing process automation, you improve the team’s morale. Firstly, they get more focus time for deep work and designing better...

Companies that Trust SPK and Associates

What our clients say

Their talent is top notch and augments and deepens our engineering capabilities in technical areas where we lack expertise and cannot add dedicated personnel. 

Ramanan P.

Leading Medical Device Manu.

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

Ximedica

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 B.

Leading Medical Device Manu.