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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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Nemko: Navigating Global Market Access and Compliance

NemkoJune 2, 20261 min read

Updated guidance on cybersecurity for medical devices in USA

The federal U.S. authority Food and Drug Administration (FDA) is, amongst other, ...
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NemkoMarch 2, 20261 min read

Strengthening of services to the Korean medical device industry

Nemko Korea has entered into an MoU with Seum Partners Co. Ltd.in order to strengthen its ...
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NemkoMarch 2, 20261 min read

Evolving governance landscape for AI

The governance landscape for artificial intelligence is evolving rapidly. Regulations ...
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NemkoMarch 2, 20261 min read

Plan to simplify the EU regulations for medical devices

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Paul SpencerAugust 28, 20251 min read

FDA QMSR Transition: What U.S. Manufacturers Need to Know

The U.S. Food & Drug Administration (FDA) has finalized its new Quality Management ...
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NemkoAugust 1, 20251 min read

The growing role of electricity and electronics in the medical fields

The medical device market continues to expand with advancing technologies and increased ...
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NemkoJune 2, 20251 min read

Powering of electronic wearables

The market for electronic wearables is booming, not least in the medical field with the ...
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NemkoApril 1, 20241 min read

Successful 2024 KIMES Exhibition Highlights in Seoul

The annual Korea International Medical & Hospital Equipment Show (KIMES) took place ...
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Juan Manuel GonzalezMay 3, 20223 min read

The Transition Period Ending: Ensure Compliance with EN 60601-1-2:4.0 and 4.1

Electrical and electronic devices will always generate some level of unwanted ...
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Andreas NilssonFebruary 10, 20213 min read

Essential Documentation Checklist for Medical Device Approval

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