Life changing solutions for medical device companies

 

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.

 

Partnership

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.

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Who we work with

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.

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Match made in heaven

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.

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End Result?

A turnkey solution that solves an unmet market need at an affordable price and is ready for market impact.

 

Focused and Fast R&D

With a intense focus on problem solving we deliver a marketable solution faster than most other product device development companies.  We will bring your product through all phases of development from concept through product realization to market release. 

 
 
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Phase 1: Concept

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Phase 2: Feasibility

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Phase 3: Qualification

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Phase 4: Design Transfer

 

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

 
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Research & Development

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Verification & Validation

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Pilot Manufacturing

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 such as catheters to heart pumps and everything in between.  Check out some of our work and get in touch.

 

 
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Vortex

Vortex is a catheter that vacuums out fresh, soft thrombi or emboli that have accumulated in the blood and need to be removed.

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

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Rap

RAP enables patients born with weak or non-existent right ventricles in their heart to live longer, healthier and better lives.

 

We're located in a 4100 square foot facility right off the 101 in the green-roofed industrial park.  We'd love for you to stop by, meet the team and see where the magic happens.

 

 
 

Address:

Sirius Engineering LLC

1100 Industrial Rd #16

San Carlos, CA 94070

Phone: (650) 453-2020

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