Medical Device Labeling Compliance That Reduces Risk & Delays

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Comprehensive Labeling Reviews for Global Regulatory Compliance

Medical device labeling is one of the most common sources of FDA citations, and one of the most overlooked. Many companies assume their labeling is compliant, only to face delays, recalls, or enforcement actions later. Confusion around UDI formatting, symbol use, translation requirements, and usability testing often leads to gaps that impact approvals and market access.

Isaac Erickson assists medical device teams in eliminating these risks with detailed, standards-based labeling reviews. Whether you’re unsure if your labels meet FDA 21 CFR Part 801 or struggling to align with ISO 15223-1 and EU MDR, he ensures your content is clear, compliant, and ready for regulatory review. Our goal is to remove the guesswork and help you avoid costly mistakes before they happen.

Common Labeling Pain Points And How We Help

Regulatory Uncertainty

Many teams are unclear on what the FDA, EU MDR, or ISO standards actually require. Isaac translates complex regulations into clear action steps and identifies gaps that could trigger rework or rejection.

UDI Implementation

UDI is not just a barcode. It requires precise formatting, database submission, and ongoing maintenance. Isaac guides you through FDA’s GUDID system, helps choose the right issuing agency, and ensures global compatibility across EUDAMED and other systems.

Translation and International Readiness

High-risk devices often require formal usability testing. Isaac works with teams to validate Instructions for Use (IFUs), risk warnings, and content structure to reduce misbranding risks and improve user safety.

Post-Market Changes

Modifications after launch can trigger new regulatory filings. Isaac helps assess whether changes to the label, device design, or intended use require new submissions—avoiding surprises during audits.

Other IMDS Services

medical device

510(k) FDA Compliance Submissions

Isaac aligns each submission with FDA expectations to streamline review, avoid submission errors, reduce delays, and minimize the risk of AIQs.

UDI barcode

UDI Implementation

Isaac helps companies implement and manage UDI systems that meet FDA 21 CFR Part 830 and align with international standards like EU MDR and EUDAMED.

International Product Regulations

International Product Regulations

Isaac can guide you through registration, documentation, and post-market obligations—so you can enter new markets without delays or costly setbacks.

Isaac Erickson

Get Expert Guidance Before Problems Arise

Labeling is more than a compliance task, it’s a critical component of your product’s safety and marketability. Isaac provides hands-on support to make sure your labeling holds up under FDA review, international scrutiny, and internal quality audits. Whether you’re launching a new product or updating existing documentation, he’ll make sure your labeling strengthens your compliance posture and speeds up approvals.

Let’s make your labeling a competitive advantage—not a regulatory bottleneck.

Get Started Now
or call (651) 353-7806

FREQUENTLY ASKED QUESTIONS

You Have Questions, We Have Answers

What are the basic regulatory requirements for medical device labeling?

Medical device labeling must comply with FDA regulations (21 CFR Part 801) in the U.S. and EU MDR requirements in Europe. Generally, labeling must include:

  • Device name and model
  • Intended use and indications
  • Manufacturer’s name and address
  • Instructions for use (IFU)
  • Warnings, precautions, and contraindications
  • Unique Device Identification (UDI) for traceability

Each country has specific formatting, language, and content requirements, making compliance essential.

Yes, many countries require labels to be translated into their official languages. For example:

  • EU MDR mandates multilingual labeling based on target countries.
  • Canada requires English and French labels.
  • Latin American markets like Mexico, Peru, and Colombia require Spanish translations.

Failure to comply with local language requirements can result in regulatory rejections or delays.

Symbols are commonly used to replace text-based information for universal understanding and space efficiency. Medical device labeling must comply with:

  • ISO 15223-1 (Standard for medical device symbols).
  • IEC 60601-1 (For electrical medical devices).
  • EU MDR & FDA guidelines on standardized symbols.

Using incorrect symbols or failing to provide a symbol glossary in the IFU can lead to compliance issues.

Labeling compliance doesn’t end at product launch. Regulatory agencies require ongoing updates and surveillance, including:

  • Labeling revisions for safety updates, recalls, or regulatory changes.
  • UDI data maintenance in global databases.
  • Periodic audits to ensure continued compliance.
  • Changes in manufacturing locations or distribution that may affect labeling requirements.

Companies must monitor global regulatory updates to ensure labeling remains accurate and compliant.