Labeling
Explore medical device labeling solutions that guarantee compliance and safety. Ensure accuracy and traceability in your products.
Life Science Outsourcing provides medical device labeling solutions that ensure accuracy, compliance, and traceability for regulatory approval and end-user safety.
Regulatory-Compliant Labelingas Part of Our End-to-End Solutions
LSO provides precision labeling that integrates seamlessly into our end-to-end medical device solutions. From FDA UDI compliance to barcode tracking, we ensure accuracy, traceability, and regulatory approval—helping you bring products to market with confidence.
What is Labeling?
Medical device labeling encompasses printing, application, and verification of product information to comply with industry regulations and ensure patient safety.
- UDI (Unique Device Identification) labeling: Compliance with FDA and global regulations.
- Sterile & non-sterile labels: Designed for medical-grade packaging.
- Barcoding & traceability: Ensuring full product lifecycle tracking.
Who Needs Labeling?
- Medical device manufacturers requiring FDA-compliant labeling.
- Distributors & suppliers managing traceability and inventory.
How Does Labeling Work?
- Label Design & Regulatory Review: LSO collaborates with clients to design labels that meet FDA UDI regulations and international labeling standards. Each label undergoes a compliance review to ensure accuracy, readability, and durability in various environments.
- Printing & Application: Labels are produced using high-quality, medical-grade printing techniques to ensure longevity and compliance with sterilization methods. LSO offers automated and manual label application solutions to ensure precision and adherence to packaging materials.
- Inspection & Verification: Each label undergoes a rigorous quality check to ensure legibility, proper adhesion, and compliance with regulatory requirements. Verification systems include barcode scanning, durability testing, and visual inspections to prevent labeling errors.
- Compliance Documentation: LSO provides comprehensive documentation, including labeling validation reports, regulatory submission support, and traceability records to ensure full compliance with FDA, ISO, and global requirements.
What standards apply?
- FDA UDI Rule (21 CFR 801) – Unique Device Identification requirements.
- ISO 15223-1 – Labeling symbols and information.
- GMP labeling requirements – Ensuring accuracy and compliance.
Why LSO?
- Full regulatory compliance with UDI and global standards.
- Advanced printing & verification to prevent labeling errors.
- Seamless integration with packaging and distribution services.
Full EtO Validation
Comprehensive packages for regulatory compliance.
Flexible Sterilization Cycles
From fractional to full cycles with EtO residual testing.
Robust Qualification
Secure with 2X qualification.
Choice of PCDs
Tailored to your sterilization needs.
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