Client Need:
- Innovative start-up developing pulsed field ablation (PFA) for therapeutic use in pulmonology
- Software development and hardware/software integration for CE Marked system
- Manufacturing of CE units for human clinical
How RBC Added Value:
This multiple phase project was initiated while the client was mid-way through project work with another contract manufacturer. RBC was contacted to aid in project rescue work to keep the client’s goals and timelines on track. RBC was able to transfer the design into its ISO 13485 Quality System and complete all development work to get the system completed and manufactured for US clinical study use. A parallel project was scoped for design verification and validation for the CE marked system, followed by a pilot phase. This included rebuilding and integrating software modifications and necessary product enclosure updates. RBC was also contracted through manufacturing for units to be used in European clinical studies.
This client returned for a subsequent and unique development project that would assist them in determining viability to leverage platform technology across other applications.
