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Greenlight Guru for Quality in Medical Devices

Greenlight Guru takes the approach of helping companies focus on quality, not JUST compliance.  By doing so, companies are more innovative and productive, and instill customer confidence and loyalty that their devices will perform as intended.  

By partnering with Greenlight Guru, SPK seeks to join them in their vision to innovate in the medical device industry to provide a foundation of compliance, quality, and technology.  Learn more about Greenlight Guru by speaking with SPK’s experts today!

Learn about Greenlight Guru from a Trusted Partner like SPK!

Lead with Quality

For far too long, the medical device industry has believed that happy inspectors lead to quality products. This is simply not true. FDA and ISO registrars know it as well. In A Case for Quality, an ongoing joint effort program between FDA and the industry, a new vision for the relationship between quality and compliance is made clear.  Below is a quote from A Case for Quality.

“Medical device manufacturers can reduce costs and increase their profits by focusing on quality measures during medical device design and production. This quality improvement approach pays dividends in customer satisfaction and provides significant competitive advantages.

In simple terms, our review of device manufacturers that consistently produce high-quality devices identified that an investment in quality has long-term payoffs. Quality of medical devices is in everyone’s best interest.”

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.

Recent Resources

Product Design: How to Eliminate 6 Bottlenecks 2022

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Cloud Based Solidworks — Powered By vCAD

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https://youtu.be/4bSvsijnGWE Hi my name is Daniela and I am the Solidworks PDM SME for SPK and Associates. Today we'll be covering how to use cloud based SolidWorks inside vCAD. How to use cloud based SolidWorks within vCAD vCAD is a really handy tool that allows you...

PDM SolidWorks Tutorial: Installation Manager

PDM SolidWorks Tutorial: Installation Manager

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