We believe that rapid agile development of innovative medical devices should not be at the expense of rigorous regulatory compliance. Medical device companies need both in order to succeed in today’s healthcare market.
Close collaboration and communication with your team is a priority for all of our projects. We provide:
Aaron JosephPrincipal Consultant
Aaron has over 20 years of experience in medical device development. He’s been involved in over 50 development projects in 26 different quality systems. Aaron’s experience covers a wide range of products: surgical robotics system, digital x-ray fluoroscopy system, heart-lung bypass machine, robotic catheter system, x-ray catheter for brachytherapy, laser eye surgery system, endoscopy instruments with RF ablation, and multiple IOT products.
Aaron is an avid promoter of lean and agile methods and helps clients to efficiently comply with regulatory requirements for software and hardware development. He works closely with product development teams in performing risk analyses, developing test plans and protocols, managing product requirements, refining design control procedures, and training R&D staff. Aaron is an expert at medical device design verification and validation, including software, hardware, and system testing.
He is able to apply design controls efficiently and rigorously to a broad range of products and adapt them to small and large organizations.
Aaron has a BS in Electrical Engineering from Rice University and a MS in Bioengineering from University of Washington.
What’s In A Name
Historically, the sunstone was a fabled crystal that enabled Vikings to sail the vast open stretches of sea between Scandinavia, Iceland, Greenland and modern-day Canada, even with zero visibility of the sun. The calcite crystal possesses a unique ability to polarize light, splitting light rays to reveal the direction of the sun with surprising accuracy. This enabled Viking sailors to determine the position of the sun even when it was hidden by heavy cloud or masked by fog.
But of course, a sunstone is only as good as its “pilot:” Successfully navigating the open seas depended on an experienced Viking at the longboat’s helm, in possession of both the sunstone crystal and the expertise to use it effectively.
Similarly, Sunstone Pilot consulting provides product development teams with both sophisticated tools and the experienced guidance to help them successfully navigate regulatory compliance.
We can connect you with additional expertise through our collaboration partners:
Irwin & Associates provides expert consultants in quality engineering, technical writing, manufacturing engineering, and related areas for medical device companies.
Consensia provides software tools for managing complex product development, including the ZipQuality system expressly configured for medical device companies.
Matrix Requirements provides Quality Management System (QMS) and Application Lifecycle Management (ALS) software for medical devices.