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Labeling and Packaging for Medical Devices

Ensuring compliance and product integrity

Packaging & Labeling

What is IT and why is it critical?

Labeling and packaging are essential stages in the medical device lifecycle. They ensure not only correct usage and patient safety but also product integrity during transportation, storage, and application. These processes are tightly regulated by global authorities such as the FDA and the European Commission, and must comply with strict technical standards. Inadequate labeling or packaging can result in non-compliance, product recalls, or patient risk—making these services mission-critical for OEMs, hospitals, and global distributors.

Key Benefits

  • Global regulatory compliance
    Adheres to FDA 21 CFR Part 801, EU MDR 2017/745, ISO 15223-1, and ISO 20417.
  • Full product traceability
    Incorporates Unique Device Identifier (UDI), expiration date, lot/batch number, and storage conditions. <b.
  • Sterility and product protection
    Maintains barrier integrity for sterile and non-sterile products through validated primary and secondary packaging.
  • User safety and clarity
    Includes legible labels, warnings, handling instructions, and device identification across all packaging levels.
  • Audit readiness and recall support
    Enables swift product retrieval and regulatory inspection with complete, accessible documentation.

Key Factors

  • Mastery of evolving regulations
    Capability to navigate and implement global labeling and packaging requirements.
  • Validated packaging processes
    Compliance with ISO 11607-1 and 11607-2 for terminally sterilized medical devices.
  • UDI integration and barcode accuracy
    Systems in place for proper UDI placement and scannability across packaging formats.
  • Seal integrity and tamper evidence
    Testing methods aligned with ASTM D4169 for shipping durability and seal validation.
  • Design for safety and usability
    Labeling systems optimized for legibility, compliance, and end-user understanding.

Certifications

RexMed's Competitive Edge

RexMed delivers fully compliant and quality-assured labeling and packaging services, grounded in international standards. Our processes support the full range of packaging—from primary sterile barriers to third party transport solutions—with attention to traceability, regulatory alignment, and patient safety.

We incorporate tamper-evident technologies, validated sealing methods, and documentation protocols that enable product accountability and ease of audit. Every label, barcode, and package is designed to meet the highest expectations of regulatory bodies and end users alike.

Let’s align your packaging strategy

With ISO 11607 and global labeling requirements we are ready to take your project to new heights.

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FAQ

Our packaging is tested using ASTM D4169 protocols to simulate distribution and ensure seal strength, durability, and sterility maintenance.
Yes. We support custom UDI formats, label design, and placement aligned with your internal systems and international regulations.
Absolutely. We conduct Installation (IQ), Operational (OQ), and Performance (PQ) Qualifications per ISO and FDA requirements.
We manage primary (device contact), secondary (boxes), and tertiary (shipping containers) packaging with complete traceability and protection.
Yes. Our processes are aligned with FDA, EU MDR, ISO 15223-1, ISO 20417, and validated packaging standards.