Medical Device Qualified Supplier Directory
Stellartech Research Corporation Company Profile
Qualifications: ISO 13485, FDA Registered, Supplier to Medical Manufacturers
Markets Supplied: North America, Europe
Stellartech designs, develops and contract manufactures medical systems utilizing radiofrequency, ultrasound and other energy sources. Typically combining a disposable patient-contact device and a microprocessor-controlled instrument, these systems incorporate complex electronics for sensor feedback and controlled delivery of therapeutic energy.
We also develop and manufacture complex diagnostic systems, and a range of patient contact devices such as surgical probes, balloon electrode catheters and other catheters for minimally invasive therapies.
Working with companies of all sizes, we take a product idea from concept through proof of principle, clinical evaluation, regulatory approval and manufacturing. We also work directly with entrepreneurs, physicians and investment groups to incubate new device enterprises as "virtual companies" using Stellartech infrastructure.
Stellartech functions as your business partner through every stage of the product development process. Because we have experience in the scientific and clinical principles underlying your new application, as well as the business and regulatory environment in which you operate, we are able to add value at each stage-from initial concept to market introduction.
Stellartech offers you the resources of a world class design, development and manufacturing group. Our expanded 63,000 sq. ft. facility permits us to produce a wide array of Class II and Class III devices under our QSR and ISO 13485:2003 Quality System.
- Interventional cardiology
- Interventional radiology
- Cardiac electrophysiology
- Cosmetic surgery
- General surgery
- Manufacture of Class II and Class III devices
- FDA registered, California licensed, ISO 13485:2003 certified manufacturing facility
- Controlled environment for manufacture of catheters, surgical tools and other sterile devices
- Electronics manufacturing area for fabrication, product assembly, final test and packaging
- In-house MRP system & rigorous document control
- PCB inspection and testing
- Complete post-production service capability
The Stellartech Advantage
- We work with a wide range of energy modalities including radiofrequency (RF), ultrasound, microwave, high voltage and cryogen
- We are experts in the design of electronic, electromechanical, mechanical, user interface and software systems and can integrate these elements into complex systems
- We are experienced in the development of disposable catheters, probes and other patient-contact devices for diagnostic and therapeutic procedures
Concept and Feasibility Phase → Prototype Development Phase → Pilot Manufacturing Phase→ Manufacturing Phase
- Tight control of schedules, costs, results
- Value-added activities including helping to guide your regulatory strategy or develop your intellectual property portfolio
- Continuous communication
- Commitment to clinical success
For more information contact Stellartech Research Corporation