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 ManufacturingA 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. |