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
The Key to Reducing Costs and Improving Product Quality
Introduction Michael Roberts: Hello and welcome to this SPK Vlog entitled The Key to Reducing Costs and Improving Your Quality. My name is Michael Roberts, Vice President of Sales and Marketing here at SPK and Associates. I'm here today with Daniela. Feel free to...
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...
Accelerating NPI/NPD Cycles: Strategies for Faster Time-to-Market
Quickly bringing innovative products to market is every manufacturer’s goal. To make that happen, companies often rely on two key processes: New Product Introduction (NPI) and New Product Development (NPD). NPI focuses on the manufacturing and launch phases, while...