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Practical resources for navigating compliance, testing, and global market access.

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Expert insights on compliance, testing, certification, and evolving regulatory requirements.

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Verify certificate authenticity and certification status through Nemko’s online platform.

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Find Nemko locations worldwide and connect with local experts for testing, certification, compliance, and global market access services.

In vitro diagnostic (IVD) products

Obtain all relevant approvals and certifications for your IVD products

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In vitro diagnostic (IVD) products certifications

In vitro diagnostic devices are medical diagnostic tools and accessories that are used in testing or screening clinical samples, including blood and tissue. In this way, health professionals are able to detect infection or a medical condition. Ultimately, IVD devices can prevent disease. 

Our laboratory engineers provide a full range of testing using the latest lab equipment. They have expertise in biotechnology, chemistry, materials and polymer science, and will support you with cost-effective solutions in the development and approval of your IVD products. Make sure that the IVD devices quickly reach the people who need them the most by accelerating the process of obtaining all relevant certifications. This means that you will swiftly gain access to international markets. 


At Nemko, we work closely with manufacturers of IVD (in vitro diagnostic) products to reduce time-to-market across the world, and to achieve compliance without complexity. 

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IVD medical devices

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

Product Testing

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

Product certification

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

Global market access

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

Cyber assurance

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

Management system certification

Management System Certification

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

Pre-compliance testing

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

Field Evaluation

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.

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