IEC 60601-1 Pre-Compliance Evaluation

We test your device and associated documentation at any stage of development, mitigating the cost of repeated certification & compliance testing by evaluating potential non-compliances.

IEC 60601-1 Pre-Compliance Evaluation for medical electrical devices

In order to comply with MDR requirements, medical electrical device (ME device) manufacturers must send their products to a certification test house and meet the many requirements laid out in IEC 60601-1. This is a costly and challenging process – it is exceedingly rare for a device to pass the requirements first time – often taking years of work and tens of thousands of pounds in costs.

At Test Labs, we offer an IEC 60601-1 pre-compliance evaluation service to help manufacturers avoid expensive repeat testing with a certification test house. Before you submit your device for compliance testing, Test Labs will perform a review of the associated documentation of a device (such as the risk file, markings, instructions for use (IFU), etc.), test the device for compatibility with the IFU using repeated cleaning, disinfection, and sterilisation cycles, and perform basic electrical, mechanical and temperature safety tests.

We can also perform optional tests, including an engineering file review (to IEC 60601-1-6 & IEC 62366), software life-cycle process review (to IEC 62304 & clause 14 of IEC 60601), and assess medical equipment used in the home healthcare environment according to the requirements of IEC 60601-1-11.

For manufacturers that also produce non-electrical medical devices, Test Labs also provides a reusable medical device reprocessing validation service.

You Need Pre-Compliance Evaluation – here’s why

Pre-compliance testing is a valuable tool for product development, as it allows you to proactively identify potential failures

FDA Medical Device Material Performance Requirements – Guide

IEC 60601-1: Everything You Need to Know

Explore our medical device testing services

Clinical Evaluation

We develop and implement procedures to collect, appraise, and analyse clinical data pertaining to your medical device.

Disinfection products for medical devices

We test the efficacy of a wide range of disinfectants for medical devices, including disinfection technologies and robots.

Material compatibility assessment

We analyse test item materials at both sample and product level to assess process compatibility

See our research & testing facilities

Microbiology Laboratory

We are fully equipped to perform a wide variety of microbiology tests using bacteria, yeast, fungi, and bacterial spores.

Test chambers

We have built state of the art Test Chambers – all with a stainless steel interior and equipped with a wide range of sensors.

Chemistry Laboratory

Our chemistry lab is fully equipped to perform a wide variety of tests, that supports formulation and materials

Strong foundations are built with robust Quality Management Systems