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