Sirius Engineering believes in developing intuitive life saving solutions to complex and challenging problems. We apply our medical device design experience to help patients affected by a multitude of medical conditions. We're a nimble product development team that strives to solve our clients and their patients' needs. We work with CEO's and startups who have a clear understanding of a clinical problem that needs solving.
We provide the complete infrastructure (R&D, Regulatory, Manufacturing and Quality) to develop a solution that can be brought to market rapidly and manufactured at scale. We work best with CEO's whose primary focus is on business development: understanding market needs, validating them and establishing the necessary contacts to make the business a viable success.
We handle the rest. We provide our partners with the leadership, expertise and infrastructure for R&D, manufacturing, regulatory and quality functions within an ISO 13485:2016 certified quality system and ISO Class 7 cleanroom.
We provide the complete infrastructure (R&D, Regulatory, Manufacturing and Quality) to develop a solution that can be brought to market rapidly and manufactured at scale. We work best with CEO's whose primary focus is on business development: understanding market needs, validating them and establishing the necessary contacts to make the business a viable success.
We handle the rest. We provide our partners with the leadership, expertise and infrastructure for R&D, manufacturing, regulatory and quality functions within an ISO 13485:2016 certified quality system and ISO Class 7 cleanroom.
Services
Founded by Tom Kramer with over 25 years of experience in medical device development, Sirius Engineering is one of the leading medical device and development firms in the Bay Area.
Sirius Engineering provides design & development and contract manufacturing services for country specific regulatory requirements to customers in the medical device market.
We take quality seriously.
We adhere to a strict Quality Management System to ensure Sirius Engineering is meeting the established objectives of our customers.
Sirius Engineering provides design & development and contract manufacturing services for country specific regulatory requirements to customers in the medical device market.
We take quality seriously.
We adhere to a strict Quality Management System to ensure Sirius Engineering is meeting the established objectives of our customers.
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