Life Science Outsourcing

Diagnostics Manufacturing Services Archives

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
ISO 17025
Accredited Packaging Lab

Diagnostics Manufacturing & Packaging Services

Our Diagnostic Services help OEMs bring microfluidic cartridges, point-of-care platforms, and automated consumables to market with confidence. We focus on precise reagent delivery, material compatibility, and long-term stability—delivered through our integrated manufacturing, packaging, and sterile barrier capabilities as a division of Life Science Outsourcing, Inc.

years of package testing expertise

devices validated across EtO, radiation, and steam

regulatory submissions supported (FDA, EU MDR)

ISO 11135 / 11137 / 17665 compliant studies

Sterilization Validation Services (SVS), a division of Life Science Outsourcing, Inc., is responsible for the sterilization and validation of single use and reusable products and related documentation. SVS promises to assist you in your choice and evaluation of the ideal sterilization methodology best suited to your product.

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

ISO 17025

Accredited Packaging Lab

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