Medical Device Label Durability Validation

Medical Device Label Durability Validation

We evaluate medical device packaging, labels, and markings to ensure their durability and integrity throughout the device’s lifecycle.

1 Report Delivery

3-5 Weeks

2 Finished Product testing

3 Bulk Product

Batch Testing

4 Life Cycle Testing

5 Verification Testing

We’ve relied on Test Cert for multiple medical device testing projects, and they’ve never disappointed. Their team has deep knowledge of ISO 21530 and other relevant standards. Their timely, well-documented test reports helped us meet both local and international regulatory requirements with ease.”
– Dr. Ayesha Malik, Regulatory Affairs Manager, Meditech Solutions.

List Of Tests

Our Medical Device Label Durability Validation service ensures that medical device labels meet regulatory standards and industry requirements for durability and legibility. This service involves rigorous testing to validate label adhesion, legibility, and durability under various environmental conditions, ensuring compliance and patient safety.

1 Finished product testing

This involves testing the final medical device product, including its labels, to ensure they meet quality and regulatory standards.

2 Bulk product/batch testing

This type of testing involves evaluating a large quantity of products or a specific batch to ensure consistency and quality, including label durability.

3 Life cycle testing

This testing assesses the durability and performance of medical device labels over the product's entire lifespan, including exposure to various environmental conditions.

4 Verification testing

This process involves verifying that the medical device labels meet specific requirements and standards, such as legibility, adhesion, and durability, through testing and inspection.

Reviews

Fatima Riaz

Co-Founder, NovaMed Devices

Haroon Sheikh

Imran Qureshi

QA/RA Lead

As a startup in the medical device field, we needed guidance on compliance and validation. The experts at Test Cert walked us through the process and even helped interpret ISO 13485 requirements. Their clarity and support have been invaluable.

Test Cert Laboratory understands how critical timelines are in medical device registration. We were impressed with their swift turnaround and regular updates. Their team maintained clear communication from sample submission to report delivery

Test Cert Laboratory provided excellent biocompatibility and sterility testing services for our Class II medical devices. Their lab is well-equipped and their documentation is audit-ready. We felt confident submitting their results to our notified body.

FAQ

What testing standards do you follow?

TestCert adheres to international testing standards such as ISO 13485, IEC 60601 series, ISO 14971 for risk management, and other relevant ISO and FDA guidelines to ensure device safety, performance, and regulatory compliance.

How long does testing usually take?

Testing timelines depend on the scope and complexity of the device and tests required. On average, testing takes between 2 to 8 weeks. We provide estimated timelines during the project planning phase.

What types of medical devices does TestCert test?

We provide testing services for a wide range of medical devices including diagnostic equipment, therapeutic devices, implantables, in-vitro diagnostics, and more. Our services cover both electrical and non-electrical medical devices.

What types of tests do you offer?

We offer a comprehensive suite of tests including:

Electrical safety and performance testing
Biocompatibility testing
Mechanical and durability testing
EMC (Electromagnetic Compatibility) testing
Chemical and toxicological testing
Sterilization validation
Packaging integrity tests

Can TestCert test prototypes and pre-production devices?

Absolutely. We test both prototypes and production-ready devices to help you identify issues early and ensure compliance before mass production.

Do you assist with regulatory submissions?

Yes, TestCert offers consultancy to help you prepare technical documentation and test reports suitable for submission to regulatory authorities such as the FDA, CE marking bodies, and other international agencies.

Our Address

Suite # 05, Fourth Floor, Century Tower, Kalma Chowk Flyover. Lahore, 54660

Contact Information