Nearshore Solutions for Medical Device Manufacturing
Your Program Success Starts HereiiMED offers “nearshore”
manufacturing services for Class I and II medical devices. We
develop lasting partnerships built on robust, proven capabilities
and processes. Our outstanding customer care assures your products
are delivered on-time and on-budget with the highest level of
quality and precision.
Products Capabilities
• Compression Devices• Orthopedic Bracing & Soft Goods•
Patient Mobility Products• Sterile & Non-Sterile Medical
Supplies• General Cut & Sew• And Many More
• ISO Class 8 Certified Clean Room• RF and Ultrasonic Welding•
Flame Laminating• RF Tipping• Thermoforming• Specialty Sewing
Operations• Slitting, Sheeting and Diecutting
Manufacturing CapabilitiesWith nearly 140,000 square feet of
manufacturing space, iiMED’s facility in Reynosa Mexico provides a
number of key operational capabilities that allow high quality
manufacturing of your Class I or II Medical Devices.
Partnering with iiMED Adds Value
• Rapid Startup. Our experienced Project Engineers become an
extension of your team to understand requirements and manage
business and technical processes.
• Program Support. Our team’s support is broad, including
project management, material sourcing, sterilization, packaging,
import/export management and logistics.
• Flexibility. Choose the level of service that fits your need,
from consigned assembly to a full turnkey manufacturing program.
Highly scalable operations can meet fast growing demand.
• Robust Manufacturing Capabilities. Nearly 140,000 square feet
of manufacturing space in Reynosa, Mexico includes two ISO Class 8
certified cleanrooms, flame laminating, RF and ultrasonic welding
and specialty sewing operations.
• Uncompromising Quality. With an active 5S Program, our quality
systems meet or exceed industry requirements. ISO-13485:2016 and
FDA Registered Manufacturing Facility.
Market iiMED Product Capabilities
Orthopedics Orthopedic Bracing Arthroscopic Suction &
DrainageHot & Cold TherapyTrauma Fixation & Splint
Slings
Wound Care Compression TherapyPressure Relief DevicesWound
TherapyDrainage Catheters
Nephrology / Urology
Urologic CathetersOstomy & Drainage BagsDialysis Circuits
(tube-sets)
Hospital Supplies Drug InfusersProcedure Kits & TraysSuction
& Irrigation Tube SetsEndoscopic Sheaths
Patient Mobility Patient Lifts & SlingsPatient Positioning
PadsSeat Cushions & Pads
Healthcare IT Blood Pressure (BP) CuffsNeonatal BP
CuffsTelemetry Pouches
ENT / Respiratory Tracheostomy Tube HoldersAirway
CircuitsCPAP/BiPAP Headsets
iiMED | Headquarters: Amherst, NY, USA | Manufacturing: Reynosa,
Mexico | p 877.904.3162 | iimedical.com
Cleanroom ManufacturingOur ISO Class 8 cleanroom manufacturing
capability includes over 6,000 square feet of manufacturing space
with operations that include heat forming, tube cutting, tipping
and punching. We also offer in-room form, fill and seal packaging
with pouch or tray lid sealing.
Flame LaminatingOur flame laminating capability allows
lamination of a variety of materials including polyurethane,
neoprene and “pinch-able” polyethylene foam laminations. We also
offer any combination of hook & loop, scrim, tricot and woven
materials. Finished thicknesses range from .100” to .500”.
Cutting OperationsWe provide slitting, sheeting and die-cutting
and converting operations for medical films, fabrics, tapes and
papers that support nearly all finished products. Our programmable,
multi-ply CNC cutters ensure efficiency and minimal waste.
RF & Ultrasonic WeldingFrom spot welds to large scale platen
welds, iiMED’s RF & ultrasonic fabric and film welding
capability allows perimeter, connector interface, hook and loop,
tube mandrel welds and tear seals.
Specialty Sewing OperationsWith over 200 sewing stations, our
highly skilled operators provide overlock, cover stitching,
programmable stitching, single and double needle, and zig zag
stitching on a variety of textiles. Custom embroidery is also
available.
Additional CapabilitiesOther capabilities include
electro-mechanical assembly, thermoforming, kitting, silk-screen,
hot stamp, and pad printing, and a variety of packaging
methods.
Featured Manufacturing CapabilitiesWith nearly 140,000 square
feet of manufacturing space, iiMED’s facility in Reynosa Mexico
provides a number of key operational capabilities that allow high
quality manufacturing of Class I and II medical devices.
iiMED | Headquarters: Amherst, NY, USA | Manufacturing: Reynosa,
Mexico | p 877.904.3162 | iimedical.com
