Contract Manufacturing

Gilero’s manufacturing expertise ranges from single-use medical devices to complex electromechanical systems.  We focus exclusively on the medical device and drug delivery/combination product markets. With a proven capacity to innovate, scale and commercialize, our domestic and international facilities are equipped to develop unique manufacturing solutions and accelerate device commercialization timelines. Our facilities are FDA registered, ISO 13485 certified and compliant with cGMP.

Manufacturing Services

Plastic Injection Molding

– In-house injection tool building
– Single cavity, pre-production injection molds

– High cavitation, engineered hot runner, insert and two-shot injection mold systems
– Complex parts, tight tolerances
– First article inspection and CPK analysis
– Scientific molding process development
– Mold flow analysis
– Injection molding process validations
– Real-time process monitoring

Complex Assembly & Final Packaging

– Assembly capabilities ranging from manual assembly to high-speed robotics and automation
– Complex electromechanical device assembly
– Process development & process validation
– Vision inspection systems
– Dedicated form, fill and seal packaging lines
– Semi-automated thermoforming and sealing equipment
– Convenience kitting
– Sterile and non-sterile packaging
– Sterilization management

Clinical to High Volume Production

– Volumes ranging from DV&V, clinical and pilot builds to full scale, high volume production
– Design for manufacturability throughout design, development and manufacturing transfer process
– Improve speed-to-market and cost efficiencies through a single-source partner
– Ability to efficiently scale, providing a smooth transition from pilot to commercial volumes
– Management of manufacturing transfers
– Laminar Flow Hood (clean bench) assembly
– 14 certified cleanrooms

Global Manufacturing Footprint

Pittsboro, NC, USA

40,000 square feet
9 certified cleanrooms (9,000+ square feet)
4,000+ square feet of white space assembly
Clinical trial builds
High volume assembly
Electromechanical device assembly

Morrisville, NC, USA

15,000 square feet
1,500+ square feet of certified cleanroom space
DV&V, pilot and clinical builds
Process development
Co-located with Design Center

Shenzhen, China

36,000 square feet
In-house mold tool making
Cleanroom injection molding
Manual to fully automated assembly production lines
High precision machining of tooling components
Rapid tool iterations and modifications

Ready to get your device in the market?