- ISO 13485 compliant and Notified Body approved
- Hard wall, Class 7 clean room
- Separate Chemical Processing area
- On Site autoclave and chemical sterilization
- Ample bench, lab, manufacturing, office space with room for expansion including additional clean room capacity
- Skilled technicians with experience in assembly and prototyping of cardiac devices
On-site laser cutting technology: see our machine laser cutting pericardial tissue.