Efficient Solutions for Medical Devices

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 are a nimble product development team that strives to solve our clients and their patients' needs.

 
 

Focused And Fast R&D

 
 

With an intense focus on problem solving, our device development team delivers a fast marketable solution.  We will bring your product through all phases of development: from concept, through product realization, to market release. We can help you be first to market.

 

PHASE 1: CONCEPT

PHASE 2:

FEASIBILITY

PHASE 3: QUALIFICATION

PHASE 4:

DESIGN TRANSFER

LEARN MORE ABOUT OUR PRODUCT DEVELOPMENT

 

From Machine Shop to Clean Room to FDA Submission, we've got everything you need to turn your medical device idea into reality.

 
 
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RESEARCH & DEVELOPMENT

VERIFICATION & VALIDATION

PILOT MANUFACTURING

 

Our engineers will translate your idea to streamlined products. Sirius Engineering will develop your concepts and models into functional prototypes that can be challenged on the bench and in the lab. We have an iterative brainstorming, build and test philosophy so you see quickly what works - and what doesn’t. We design your products into marketable, surgeon tested devices following our FDA Quality Management System. We create test protocols for performing the necessary verification and validation bench testing. Our machine shop can produce the fixtures you need to thoroughly test your device. We will test your devices in-house using our extensive array of test equipment. Our manufacturing team will scale product production to meet the demands your idea generates from the market.

 
 

Cleanroom Manufacturing

Our certified ISO Class 7 cleanroom ensures the quality and cleanliness expected of your product. Whether a pilot line or full scale production, our manufacturing will produce fast and consistent results.

 
 

Warehousing and Distribution

We have warehousing and distribution solutions for any size project. Our controlled inventory solutions provide delivery of your device where you need it, when you need it.

 
 

Quality Assurance

Sirius Engineering is committed to a culture of quality that produces consistent results without surprises or delays. Sirius Engineering operates an effective quality management system (QMS) in compliance with ISO 13485:2016 and FDA QSR quality system requirements and regulatory requirements. We are dedicated to taking the time to understand your needs so we can fully meet your requirements. We know that every product matters and requires sound solutions to improve patient outcomes and minimize risks.

 
 

Experienced

 

Our engineers have contributed to over 200 patents and launched more than a dozen successful products. We've solved many problems with innovative solutions using catheters, heart pumps, and everything in between. Check out some of our work and see how we can help get your idea to the market.

 

TAS Medical is marketed for open and minimally invasive ventral hernia repair and tissue closure.

Cruzar Houdini is a 5Fr catheter that is marketed to cross a total occlusion with unprecedented speed.

Vortex is a catheter that is marketed for the removal of thrombi and emboli that compromise a patient’s cardiovascular system.

Partnerships

We work with innovators who have a clear understanding of a clinical problem that needs solving at any phase of your program. 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 will provide you with focused business development: understanding market needs, validating them, and establishing the necessary contacts to make your business a viable success.

If you have an idea, we can handle the rest.

The end result?

A turnkey solution at an affordable price, solutions designed with agility, and a solidly manufactured device ready to impact the market.

 

We're located in a 4100 square foot facility right off of highway 101 on the SF Bay Area Peninsula, roughly mid way between SFO and SJC airports.  Our building faces Brittan Avenue, about 1/2 block off Industrial Road. We would love for you to stop by, meet the team, and see where the innovation happens.

 

 
 

Address:

Sirius Engineering LLC

1100 Industrial Rd. Suite#16

San Carlos, CA 94070

Phone: (650) 453-2020