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

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Blog

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

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Certificate Finder

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

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Medical Device Certification

Nemko can deliver international CB certificates and EC-certificates for Europe for your medical devices.

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We cover your compliance needs for product requirements (IEC 60601 series) as well as Quality Management System requirements (ISO 13485).

We are accredited according to ISO/IEC 17065 and ISO/IEC 17025.

Product certification

Nemko provides international CB certificates for medical devices.

Medical device certification for Europe

  • Medical Device Directive, Class I-m (measuring), I-s (sterile), IIa, IIb, III
  • EC Declaration of Conformity; compiling of test reports and required documentation for the technical file (Annex VII)
  • EC Type Examination Certificate (Annex III)
  • Full Quality Assurance with reference to EN ISO 13485 (Annex II)
  • Production Quality Assurance with reference to EN/ISO 13485 (Annex V)
  • Product Quality Assurance with reference to Annex VI
  • EC Verification Annex IV

Collaborative compliance

Compliance requirements are easier to meet when they’re part of the development process, not an afterthought. Nemko helps product teams identify potential issues earlier to reduce rework and simplify the path to approval.

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

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.

Upcoming Events

EU AI Act: Latest Changes & Updates

Cybersecurity for Medical Devices: FDA & EU MDR Expectations

Nemko Italy Customer Seminar 2026

RF Compliance for Medical Devices: FCC Certification, RF Testing & FDA Considerations

Compliance for Industrial Innovation @ SPS in Nürnberg

SPS Expo - Smart Production Solutions 2026

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Dedicated global partner

No matter if you are located in Europe, Asia, North America, or anywhere else in the world, Nemko’s international testing and certification facilities are here to help.
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