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
Accelerating Product Development the SPK Way
Developing high-quality products quickly can be a challenge without the proper tools, processes, and partners to help. Dive into this eBook to discover how partnering with SPK can help you achieve product development success.What You Will Learn In this eBook, we will...
EU Digital Operational Resilience Act Compliance 101: What Financial Institutions and ICT Providers Need to Know
Digital disruptions such as cyberattacks or system failures are one of the largest threats to the financial sector. Recognizing the increasing reliance on digital infrastructure, the European Union introduced the Digital Operational Resilience Act (DORA). This act...
Navigating the High Costs of Product Launch Delays
Delaying a product launch can have significant financial repercussions that extend far beyond the immediate costs. It is important to understand how these delays can impact an organization. Having this knowledge can transform an organization’s strategic plans and...