What should really trigger a CAPA?

When should a problem with a medical device trigger a CAPA (Corrective Action and Preventative Action)? Jon Speer at Greenlight Guru has some thoughts.  Jon Speer, Greenlight Guru After years of working with medical device companies, we’ve found that there is a particular area that is often rife with issues for companies: CAPA (Corrective Action and Preventative Action).

Greenlight Guru adds Grow to quality management software platform

Greenlight Guru recently announced the introduction of its Grow software product to assist medical device companies with quality management after product launch. The Indianapolis-based company’s first product, Go, focused on helping medtech companies utilize design control, risk management and document management software to bring FDA and ISO-compliant medical devices to market in less time. Many

greenlight.guru closes record-breaking third quarter

The quality management software platform greenlight.guru has reported that it has closed its third quarter as a record-breaking quarter, making it its fourth record-breaking quarter in a row. The company grew its team by 40% in the last quarter by adding eight new members, two of which were senior level. Jennifer Kier and Thomas Stergar

How to define and decode your design inputs and design outputs

Jon Speer, Greenlight.guru It’s a topic that confuses a lot of medical device developers: How well have you defined your design inputs and design outputs? I see some common mistakes happening there so it’s time to “decode” the two and take a look at what you can do to make your job easier down the line,

How medical device risk management is connected with design controls

Medical device design controls play an important role when it comes to risk management, but the relationship isn’t always immediately clear. Intended use is especially important, says Jon Speer, founder of Greenlight.guru (Indianapolis), which markets a cloud-based quality management software. “If you don’t have a clear order or boundaries for conducting your risk management activities,

Medical device product development: 7 pitfalls you need to avoid

Jon Speer, Greenlight.guru Managing your medical device product development project can be a daunting task. There are regulations and paperwork to manage, along with expectations such as deadlines or goals for getting the device to market. I sat down recently to chat with Peter Sebelius about our thoughts on project management best practices for medical