Greenlight Guru for Quality in Medical Devices
Focusing on Compliance is the Problem, not the Answer.
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
7 Steps for Implementing ISO 9001 Quality Systems Successfully
Implementing a Quality Management System (QMS) that ensures compliance with ISO 9001 is a strategic decision for organizations. Implementing this system enhances customer satisfaction, improves efficiency, and drives continuous improvement. However, achieving ISO 9001...
Boosting Design Collaboration So Engineers Can Innovate Together More Effectively
When developing products, design collaboration is critical to reducing miscommunication and improving design quality. Engineers and designers must work seamlessly, sharing ideas in real time to ensure that everyone is always working with the latest data. PTC’s Creo+...
Reworking Your Workflow for Better Product Design
Designing and developing a product is typically done similarly across industries. Multiple engineers work on the design until it eventually makes its way to market. However, there may be a more efficient way to design products. Explore how PTC Creo is altering the...