Accelerate Your Urology & Gynecology Device Production
End-to-End Assembly, Kitting, Packaging, and Sterilization Services
Urology & Gynecology Device Expertise
Urology and gynecology medical devices require precision engineering, strict sterility, and full regulatory compliance to ensure patient safety and effective treatment. With increasing FDA and ISO oversight, manufacturers must meet stringent regulatory requirements while optimizing production efficiency and time-to-market.
LSO partners with leading and emerging urology and gynecology device OEMs to provide scalable, compliant, and cost-effective solutions for assembly, kitting, packaging, and sterilization. Our integrated services streamline production while ensuring the highest standards of quality and regulatory adherence.
Urology & Gynecology Device Capabilities
Life Science Outsourcing offers specialized expertise in the manufacturing, packaging, and sterilization of urology and gynecology devices.
Cleaning & Decontamination
We provide precision cleaning and decontamination to eliminate contaminants, ensuring urological and gynecological devices meet sterility and biocompatibility standards.
Cleanroom Assembly & Kitting
From catheter-based devices to complete procedural kits, LSO delivers turnkey cleanroom manufacturing and kitting solutions tailored to urology and gynecology applications.
Labeling
Our in-house labeling capabilities ensure full compliance with FDA, ISO, and UDI (Unique Device Identification) regulations while maintaining the highest quality standards.
Sterilization
LSO offers contract sterilization and validation services designed for both single-use and reusable urology and gynecology devices, ensuring regulatory compliance and patient safety.
Product Portfolio
- Ureteral and Foley catheters
- Urological stents and drainage systems
- Female pelvic floor repair implants
- Hysteroscopy and laparoscopy instruments
- Endometrial ablation devices
- Urinary incontinence implants
- Gynecological biopsy and diagnostic instruments
Why LSO?
Specialized Expertise for Urology & Gynecology Device OEMs
Urology and gynecology devices require extreme precision, sterility, and compliance to ensure safe and effective patient outcomes. LSO’s integrated solutions help manufacturers streamline production while ensuring the highest industry standards.
- Faster Time-to-Market
Reduce regulatory bottlenecks and accelerate product approvals with seamless cleanroom assembly, kitting, packaging, and sterilization services. - Regulatory & Compliance Expertise
Ensure compliance with FDA, ISO 13485, and biocompatibility requirements with our industry-leading regulatory support. - Cost-Effective, Scalable Solutions
Minimize costs with fully integrated in-house services designed to support everything from prototype development to full-scale commercialization. - End-to-End Manufacturing & Sterilization Expertise
From catheter assembly to validated sterilization and packaging, we provide a one-stop solution for urology and gynecology device manufacturers.
