Rapid Research and Prototyping
The core strength of TSO3 is its ability to conduct rapid research, development and prototyping of medical reprocessing systems. TSO3 has developed an experienced team with skill sets in the following areas:
- Designing medical device sterilizers
- Testing and documenting sterile efficacy
- Regulatory submissions and compliance
- Validation of compatibility, functionality and biocompatibility
The TSO3 Quality System is certified to ISO 13485 standards and as well as compliant with CMDCAS.
TSO3 also has certification that the sterilizer and accessories are in compliance with the requirements of the European Community for Medical Devices Directive as we have obtained the authorization to use the CE mark on the aforementioned devices.
The TSO3 Quality Policy is aimed at continuous improvement by periodic reviews of performance and customer satisfaction.
TSO3, with its development capabilities and supporting infrastructure, offers medical device companies a wide range of collaborating opportunities, from contract development of unique sterilizing platforms to sterilization efficacy and compatibility services, including verification, validation and performance testing. To learn more about our services or about these opportunities, contact us at firstname.lastname@example.org or 1-866-715-0003.
Currently under development is a smaller footprint sterilizer, based on the STERIZONE TECHNOLOGY® and intended for the OR Sub-Sterile Area. Benefits of this smaller concept:
- Offers terminal sterilization for short flexible endoscopes directly in the OR
- Potential placements (North America): 7,500 units
- 50% of customers surveyed expressed interest in the concept