Medical Device Packaging Development & Production
Custom medical device packaging design, thermoforming, and ISO 11607-validated solutions from FDA-registered, ISO 13485-certified experts.
Accelerate your product launch with FDA-registered, ISO 13485-certified manufacturing. From cleanroom assembly to packaging, labeling, and sterilization—LSO delivers compliant, turnkey solutions for medical devices and implants.
Custom-Engineered Packaging Solutionsfor Medical Devices
Medical device packaging is more than just a container—it's a critical component of product safety, sterility, and regulatory compliance. At Life Science Outsourcing (LSO), we provide comprehensive packaging development and production services designed to ensure regulatory compliance, durability, and a streamlined path to market.
As an FDA-registered, ISO 13485-certified contract manufacturer, our in-house packaging expertise includes custom design, thermoforming, and pre-validated sterile barrier solutions to accelerate commercialization while minimizing risks and costs.
Looking for expert medical device packaging solutions?
Comprehensive Medical Device Packaging Services
Package Design & Development
Developing the right medical device packaging requires precision engineering, regulatory expertise, and validation testing. LSO’s package design and development services include:
- Custom sterile barrier system (SBS) development
- Material selection to ensure durability and compliance
- ISO 11607-compliant design and validation testing
- Prototyping and small-batch production for rapid iteration
Thermoforming for Medical Device Packaging
LSO specializes in precision thermoforming for rigid and semi-rigid medical device trays, providing protection, sterility, and ease of use. Our capabilities include:
- Custom thermoformed trays for implants, instruments, and consumables
- Material selection for PETG, HDPE, PVC, and Tyvek® compatibility
- Validated processes to meet FDA and ISO 11607 standards
- Prototype development and high-volume production
Pre-Validated Packaging Solutions
For medical device manufacturers looking to accelerate time-to-market, LSO offers pre-validated sterile packaging solutions that eliminate the need for lengthy validation processes. Our pre-validated packaging services include:
- Off-the-shelf sterile barrier systems with ISO 11607 validation
- Reduced time and costs associated with packaging compliance
- Multiple size and material configurations to fit various devices
- Turnkey solutions for faster regulatory approval
Why LSO?
- FDA-Registered, ISO 13485-Certified – Ensuring compliance with the highest industry standards
- End-to-End Manufacturing & Assembly – From prototyping to full-scale production
- Bicoastal & Nearshore Operations – Facilities in California, New Hampshire, and Costa Rica for cost-effective, scalable solutions
- Quick-Turn Services – Faster sterilization, validation, and lot release to accelerate market entry
- Proven Expertise in Medical Devices – Supporting orthopedics, neuromodulation, cardiovascular devices, and more
FDA-Registered
Manufacturing Facility
ISO 13485
Certified Quality System
12 Cleanrooms
Class 5–8
125,000+ Sq Ft
Regulated Manufacturing
3 Facilities
CA | NH | Costa Rica