Medical and Healthcare Equipment Testing and Certification

Certified by Nemko.
Trusted by the world.

Manufacturers worldwide trust Nemko’s independent testing and certification to ensure product safety, compliance, and global market access.

Discover Nemko Certification

Global trust starts with certified products

Gain access to global markets with Nemko’s independent testing, certification, and worldwide compliance expertise

Explore Global Market Access

Your Trusted Partner in Product Certification

From testing to certification, Nemko helps manufacturers ensure safety, compliance, and global market access.

Talk to Our Experts

Nemko electrical medical device testing services offer unmatched support in the field of testing, inspection, and certification. Nemko can confidently guide your organization through the complex certification and approvals process with ease.

Choosing Nemko as a partner will reduce cost and time to markets. Nemko test reports and certificates are recognized and accepted for national approval applications.

Optimising the approval process

You get test reports according to international standards for safety, EMC, telecom and environmental requirements to demonstrate conformity with national requirements.

We perform quality management audits as joint audits for several countries.

We are your local partner

By contacting your local Nemko team you get access to our experts. They are handling your projects and following up on the delivery. Nemko has test facilities for healthcare equipment in America, Europe and Asia.

IEC 60601-1 (General requirements for safety), IEC 60601-1-xx (Collateral) and IEC / ISO 60601-2-xx / 80601-2-xx (Particular) series of standards. Nemko can assist you to ensure product compliance within more than 50 Particular standards
CB certificates, 52 participating countries
EMC and telecom testing
RoHS testing
Reach and WEEE services
Climatic and environmental testing

Project Management Expertise

During the testing process, there can be issues that come up and stall the timeline of the project. Nemko offers complete project management expertise to avoid any unnecessary delays.

Test Preparation & Planning

Before a test can begin, there is a preparation and planning period to establish the testing schedule, which will in turn make sure your tests are performed as efficiently as possible.

Safety Testing

Medical devices are among the most highly regulated products found in the market today. Make sure your product complies with these standards to ensure the highest level of safety at all times.

Electromagnetic Compatibility Testing (EMC)

Nemko offers comprehensive global EMC testing and certification services within regulatory requirements for a wide range of electro-medical devices.

Wireless device certification

As more and more products gain wireless communication features, taking the regulations into account is mandatory for interoperability.

ISO 13485 Quality Management System

ISO 13485 is used by organisations involved in one or more stages of the life-cycle of a medical device.

Environment and sustainability

Large companies now see a need to reduce their carbon footprint and declare their level of sustainability or the sustainability of their products.

Compliance made clear

Compliance requirements can slow progress and create unnecessary risk. Nemko integrates compliance into the product development process to help teams reduce rework, simplify approvals, and move products to market with confidence.

Product testing

Make sure that risk and safety are taken care of by our internationally accredited organisation of engineers and testing laboratories.

Product certification

As your certification partner, we provide certification marks that cover numerous multinational and national certification schemes.

Global market access

Conquer global markets with confidence—uncover the regulatory requirements for your target market here.

Cyber assurance

Our cyber security team helps you understand your cyber risk levels so you can efficiently and effectively protect your assets.

Management system certification

Our highly experienced auditors provide accurate and insightful audit results to help you achieve management system certification.

Pre-compliance testing

Save your company valuable time and money by involving Nemko early in the product development process.

Field evaluation and special inspection services

As a Nationally Recognized Test Laboratory (NRTL), Nemko offers Field Evaluation and Special Inspection Services as a fast and economical alternative to traditional product safety certification.

Certified by Nemko.
Trusted by the world.

Global trust starts with certified products

Your Trusted Partner in Product Certification