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
Best Practices for Reviewing and Auditing LLM‑Generated Code
The use of Large language models (LLMs) to generate production-ready code for product engineering teams is gaining popularity. With LLM usage gaining traction, quality assurance engineers and software development managers must ensure that these LLMs meet high...
Mastering Software Supply Chain Security: How to Reduce Risk and Ensure Compliance
Software comprises an entire ecosystem of open-source libraries, third-party components, containers, APIs, build pipelines, cloud services, and developer tools. This can be referred to as your software supply chain. High-profile cyberattacks often target dependencies...
The Developer Experience Playbook: Balancing Velocity, Governance, and Talent Retention
Ensuring your developers have the proper tools and processes to eliminate slowdowns and frustrations can be the difference between a great and a poor developer experience. Discover the importance of developer experience (DX) and how to improve it in this eBook.What...