Safety. Science. Solutions.
Healthcare Safety Strategies provides usability consultation and testing throughout the medical device design and development process to keep your products on track for regulatory approval. Healthcare Safety Strategies applies FDA Human Factors guidance, IEC 62366 and 60601, and HE75.
Regardless of your need, Healthcare Safety Strategies will put together a customized plan for you. From a few hours of consultation to advise your product developers to assembling a team to conduct all formative and summative validation studies, to working with your regulatory contractor, Healthcare Safety Strategies works with your product development timeline. Healthcare Safety Strategies will obtain all clinical and patient participants for testing.