The Biomedical Device Laboratory has a dedicated clean-room to assemble and manufacture medical devices. This clean-room, known as the Controlled Fabrication Lab, is maintained under a quality management system based on 21 CFR Part 820 and ISO 13485 regulations.
Medical Device Manufacturing
A 627 square feet of laboratory space dedicated to fabricating and testing SMP foams and devices. The Controlled Fabrication Lab is clean-room capable via cupped flooring, HEPA filtration, changing vestibule, and positive pressure air flow. Cleanliness standards are within specifications for FS209E (or ISO 14644-1) as Class 100,000 (ISO 8) under environmental controls (USP 34<116>). All equipment and systems are maintained according to a quality management system based on 21 CFR Part 820 and ISO 13485 regulations. |
