1-888-310-4540 (main) / 1-888-707-6150 (support) info@spkaa.com
Select Page

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

Single Pane of Glass Dashboards: What are they?

Single Pane of Glass Dashboards: What are they?

There’s simply too much information.  We all know this.  So how can the “single pane of glass” (SPOG) dashboard simplify quantitative data? And why is data driven analytics of interest to companies? Every day, more data arrives in our inbox – text messages, reports,...

Streamlining Design Controls For A Leading Medical Device Maker

Streamlining Design Controls For A Leading Medical Device Maker

SPK helps this global enterprise to boost product development efficiencies, increase compliance reliability, generate reports with a single click, and shave weeks off their development/release cycles. The Client A respected global medical device powerhouse, with more...

Accelerating Product Development with Engineering Operations

Accelerating Product Development with Engineering Operations

What is Engineering Operations (EngOps)? Why do you need it, and how do you effectively deploy it?There’s a strange interplay between IT and engineering teams in most firms. That’s because the tech stack that engineers need to design, build, test, and release products...

Leveraging PTC Integrity for IEC 62304 Compliance

Leveraging PTC Integrity for IEC 62304 Compliance

Executive Summary Our medical device customers report that up to 70% of new product innovation is being created in the software domain. This represents an increase in both volume and complexity. In this white paper, you'll learn: The 3 different use cases explained A...

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.