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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

"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.

Recent Resources

The Business Case for Moving from ENOVIA to Windchill PLM

The Business Case for Moving from ENOVIA to Windchill PLM

With many PLM solutions on the market, it can be difficult to know which is best for your business needs. Dassault Systèmes’ ENOVIA is a popular choice as it is part of their 3DExperience platform. ENOVIA has the same goal as every PLM software which is to manage a...

A Detailed Comparison of PTC Windchill and Siemens Teamcenter

A Detailed Comparison of PTC Windchill and Siemens Teamcenter

Two of the most common enterprise PLM software on the market are PTC Windchill and Siemens Teamcenter  These product lifecycle management solutions have many similarities, but there are a few key differences that may be deciding factors in choosing one. At SPK, we...

The Role of PLM in Orchestrating the Product Digital Thread

The Role of PLM in Orchestrating the Product Digital Thread

Product Lifecycle Management (PLM) plays an important role in the manufacturing industry. Ensuring all factors of a product are well-documented is a priority for every business.  Keeping this information organized is not just a good business practice, but it...