IEC 60601-1 Pre-Compliance Evaluation

IEC 60601-1 Pre-Compliance Evaluation

We test your device and related documentation at any development stage, helping to reduce the cost of repeated certification and compliance testing by identifying potential non-compliance issues early.

1 Report Delivery

3-4 Weeks

2 Documentation Review

3 Critical Component and Insulation Review

4 Laboratory Testing

5 HALT

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 IEC 60601-1 Compliance Evaluation service helps medical device manufacturers ensure their products meet international safety and performance standards for electrical medical equipment. This comprehensive service includes a range of tests and evaluations, such as laboratory testing, Highly Accelerated Life Testing (HALT), documentation review, and critical component insulation review, to verify compliance with the IEC 60601-1 standard.

1 Documentation review:

A thorough review of technical documentation to ensure compliance with the standard

2 Critical component insulation review

An evaluation of insulation materials and designs to ensure they meet safety requirements

3 Laboratory testing

Physical testing of devices to evaluate electrical safety, performance, and reliability

4 HALT (Highly Accelerated Life Test)

A testing method used to simulate extreme environmental conditions and identify potential failure modes.

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.