Highly Accelerated Life Test (HALT)

Highly Accelerated Life Test (HALT)

Using our proprietary methods and technologies, we repeatedly operate devices and prototypes autonomously to deliver critical data within an accelerated timeframe.

1 Report Delivery

5 to 6 week

2 Medical device expected service life testing

3 Material compatibility testing

4 Basic electrical safety and essential performance testing

5 Final product and prototype 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

A testing method used to assess the reliability and durability of a product by subjecting it to extreme environmental conditions, such as temperature, vibration, and humidity, to identify potential failure modes.

1 Medical device expected service life testing

This involves testing medical devices to ensure they can perform as intended for their expected lifespan. It includes evaluating the device's durability, reliability, and performance over time.

2 Material compatibility test

This test is used to ensure that the materials used in the construction of a medical device are compatible with the device's intended use, including compatibility with bodily tissues, fluids, and other substances the device may come into contact with.

3 Basic electrical safety and essential performance test

These tests are designed to ensure that medical devices meet safety standards for electrical safety and performance. This includes evaluating the device's electrical insulation, leakage current, and other safety features to prevent electrical shock or other hazards.

4 Final product and prototype testing

This involves testing the final product or prototype of a medical device to ensure it meets design specifications, performance requirements, and regulatory standards. It includes functional testing, performance testing, and validation to ensure the device works as intended.

Reviews

Imran Qureshi

QA/RA Lead

Fatima Riaz

Co-Founder, NovaMed Devices

Haroon Sheikh

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.

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

FAQ

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 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 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

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.