## Challenge: Biocompatible Medical Device Housing
A medical device startup needed a compact, lightweight, and highly durable housing for a new portable diagnostic device. The key challenges included strict biocompatibility requirements, tight dimensional tolerances, and production in an ISO Class 8 cleanroom environment.
### Solution: PEEK Material & Cleanroom Manufacturing
Mouldible recommended PEEK (Polyether Ether Ketone) due to its excellent strength-to-weight ratio, chemical resistance, and biocompatibility. Production was conducted entirely within our certified ISO Class 8 cleanroom, ensuring contamination control. We implemented rigorous in-process quality checks and post-molding sterilization protocols.
### Results: Regulatory Compliance & Performance
* **FDA & ISO 13485 Compliance**: All parts met regulatory standards for medical devices.
* **Precision Fit**: Achieved critical tolerances for seamless device assembly.
* **Biocompatibility**: PEEK material ensured patient safety and device integrity.
* **Accelerated Time-to-Market**: Efficient production helped the client launch their device ahead of schedule.
This case study highlights Mouldible's expertise in medical device molding, combining advanced materials with stringent quality control and cleanroom manufacturing to deliver critical components.