Biowy Corporation
Biowy Corporation is a US-based medical device manufacturer and CDMO offering end-to-end product design, cleanroom manufacturing and regulatory support. The company operates ISO 7 cleanroom facilities and an ISO 13485:2016 quality management system, develops and manufactures devices and consumables for blood/cell processing, vascular access, and orthobiologics, and supports analytical testing and validation for medical devices.
Industries
Nr. of Employees
small (1-50)
Biowy Corporation
27031 Vista Terrace, Lake Forest, CA 92630 USA (Corporate Headquarters); Manufacturing Facility: 27002 Vista Terrace, Lake Forest, CA 92630 USA
Products
Processing cord blood kit
A multi-component kit and multi-chamber bags for collection, processing, separation, and cryopreservation of cord blood with lot traceability and multi-stage inspection.
Cryopreservation/freezing blood bags (DEHP-free)
DEHP-free freezing bags and multi-chamber mixing-freezing bag designs for blood and cell storage, validated for multi-cycle freeze/thaw performance.
Peripheral and central vascular access catheters (PICC / midline / port)
Single- and dual-lumen peripherally-inserted central catheters, midline catheters, and implanted access ports with power-injection-capable designs.
Tympanostomy (ventilation) tubes
Pediatric and adult tympanostomy tubes intended to provide middle-ear ventilation and drainage for otitis media management.
Bone allograft products (demineralized and mineralized)
Range of demineralized and mineralized bone allografts and scaffolds processed for surgical use, available in blocks, sheets, fibers, and particulate formats.
Topical hyaluronic acid formulation
A topical formulation based on hyaluronic acid and common preservative/excipient ingredients intended for skin hydration.
Processing cord blood kit
A multi-component kit and multi-chamber bags for collection, processing, separation, and cryopreservation of cord blood with lot traceability and multi-stage inspection.
Cryopreservation/freezing blood bags (DEHP-free)
DEHP-free freezing bags and multi-chamber mixing-freezing bag designs for blood and cell storage, validated for multi-cycle freeze/thaw performance.
Peripheral and central vascular access catheters (PICC / midline / port)
Single- and dual-lumen peripherally-inserted central catheters, midline catheters, and implanted access ports with power-injection-capable designs.
Tympanostomy (ventilation) tubes
Pediatric and adult tympanostomy tubes intended to provide middle-ear ventilation and drainage for otitis media management.
Bone allograft products (demineralized and mineralized)
Range of demineralized and mineralized bone allografts and scaffolds processed for surgical use, available in blocks, sheets, fibers, and particulate formats.
Topical hyaluronic acid formulation
A topical formulation based on hyaluronic acid and common preservative/excipient ingredients intended for skin hydration.
Services
End-to-end services from concept design and part sourcing through formulation, manufacturing, sterilization, packaging, and shipping for medical devices.
Support for QMS design and regulatory submissions, including ISO 13485 alignment and FDA 510(k) assistance.
Analytical method development and validation using FTIR, HPLC, UV and fluorophotometry, plus mechanical and freeze/thaw testing.
End-to-end services from concept design and part sourcing through formulation, manufacturing, sterilization, packaging, and shipping for medical devices.
Support for QMS design and regulatory submissions, including ISO 13485 alignment and FDA 510(k) assistance.
Analytical method development and validation using FTIR, HPLC, UV and fluorophotometry, plus mechanical and freeze/thaw testing.
Expertise Areas
- Medical device design and development
- Contract development and manufacturing (CDMO)
- Cleanroom manufacturing (ISO 7)
- Regulatory compliance and FDA 510(k) support
Key Technologies
- ISO Class 7 cleanroom
- FTIR spectroscopy
- UV-visible spectrophotometry
- Fluorophotometry
News & Updates
FDA 510(k) clearance for a tympanostomy tube product was achieved in February 2024.
FDA 510(k) clearance for a peripherally-inserted central catheter (PICC) kit was achieved in March 2020.
FDA 510(k) clearance for a PICC kit was achieved in May 2018.
FDA 510(k) clearance for a freezing/cryopreservation bag was achieved in November 2017.
FDA 510(k) clearance for a tympanostomy tube product was achieved in February 2024.
FDA 510(k) clearance for a peripherally-inserted central catheter (PICC) kit was achieved in March 2020.
FDA 510(k) clearance for a PICC kit was achieved in May 2018.
FDA 510(k) clearance for a freezing/cryopreservation bag was achieved in November 2017.