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Nemko

Name: Nemko
Address: 2210 Faraday Avenue Ste 150, Lysaker, 92008, NO
Telephone: +4722960330

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Testing • Inspection • Certification

28/10/2026

Who is responsible for CRA compliance: system integrators or original manufacturers?

This week's Ask a Nemko Expert, Pepijn van der Laan, Global Technical Director of Nemko Digital, explains why the answer is: it depends.

If you market a product under your own name or significantly modify it, you may assume CRA responsibilities. Simply integrating existing products may not trigger the same obligations.

And remember: compliant components don't automatically make the final solution compliant.

👉 Read the full answer:
https://www.nemko.com/ask-a-nemko-expert-compliance-questions-and-answers

💬 Submit your own compliance question:
https://www.nemko.com/ask-compliance-questions-get-expert-answers-from-nemko

28/10/2026

Are your cybersecurity processes ready for FDA and EU MDR scrutiny?

From risk assessments and threat modeling to vulnerability management and pe*******on testing, manufacturers face increasing cybersecurity expectations.

Join Bryan Heenan, Cyber Security Manager, for a practical discussion on strengthening compliance readiness and supporting successful regulatory submissions.

📅 November 3, 2026
🕑 2:00 PM EST
💻 Live Webinar

🔗 Reserve your spot: https://www.nemko.com/cybersecurity-for-medical-devices-webinar-2026

27/10/2026

🚨 Last Chance to Register! 🚨

Tomorrow's webinar will cover the latest updates and changes to the EU AI Act and what they mean for your organization.

As AI regulations continue to evolve, companies developing, deploying, importing, or distributing AI-enabled products need to understand their compliance responsibilities and upcoming requirements.

Join Nemko's experts to learn about:

✅ Key requirements for providers, deployers, importers, and distributors
✅ AI risk classifications and compliance obligations
✅ Important implementation timelines and milestones
✅ Impact on AI-enabled products and systems
✅ Practical steps to prepare for compliance

📅 Tomorrow, October 28, 2026
🕚 11:00 AM EST
💻 Live Webinar

🎤 Presented by Pepijn van der Laan, Global Technical Director, Nemko Digital

🔗 Reserve your spot today: https://www.nemko.com/eu-ai-act-updates-webinar-2026

23/10/2026

Sue Wolfenden attended the MedTech event in Boston this week and came away with plenty of insights from conversations with medical device manufacturers, design/build partners, and innovative startups.

Key topics included AI, robotics, cybersecurity, and the evolving regulatory landscape, including ISO 13485 and FDA QMSR.

22/10/2026

Medical device cybersecurity is no longer just a technical consideration. It's a growing regulatory requirement.

As FDA and EU MDR expectations continue to evolve, manufacturers are expected to address cybersecurity throughout the product lifecycle.

Join our upcoming webinar to learn more about:

✅ FDA cybersecurity expectations
✅ SBOM management
✅ Vulnerability monitoring
✅ Cybersecurity testing
✅ Compliance best practices

📅 November 3, 2026
🕑 2:00 PM EST
💻 Live Webinar

🔗 Register today: https://www.nemko.com/cybersecurity-for-medical-devices-webinar-2026

22/10/2026

It's a busy week for the Nemko team because we are also at FABTECH 2026 in Las Vegas, Nevada!

Peter Leshkiv is attending this year's event, engaging with machinery manufacturers, system integrators, and engineering leaders while exploring the latest advancements in fabrication, welding, automation, and production technologies.

We're proud to stay connected with the industries we support and the innovations shaping the future of industrial manufacturing and compliance.

21/10/2026

Nemko is at PACK EXPO International 2026 in Chicago, Illinois!

John Kutrzeba is attending this year's event, connecting with industry professionals and keeping up with the latest innovations in packaging machinery, industrial automation, and control systems.

We're always excited to be part of the conversations driving innovation, safety, and compliance across the manufacturing industry!

21/10/2026

Can I use one compliance strategy across multiple African countries, or do I need a country-by-country approach?

This week's Ask a Nemko Expert, David Castaneda, explains why the answer is both.

A strong global compliance strategy can help streamline approvals across multiple markets, but each African country has its own requirements, documentation, and approval processes.

The key is building a solid compliance foundation and adapting it to the specific requirements of each target market to avoid delays, added costs, and customs issues.

Want the full answer?

👉 Read the full Q&A on our website:
https://www.nemko.com/ask-a-nemko-expert-compliance-questions-and-answers

💬 Have a compliance question you'd like our experts to answer?

👉 Submit your question here:
https://www.nemko.com/ask-compliance-questions-get-expert-answers-from-nemko

20/10/2026

📢 Regulatory update for manufacturers targeting the Indian market: The BIS registration deadline for standalone Hard Disk Drives (HDDs) has been extended from November 5, 2026, to May 1, 2027.

While this provides additional time to prepare for compliance, manufacturers should start planning now to avoid delays and market access disruptions.

Nemko can support your BIS testing, certification, and global market access needs. Contact us today: [email protected]

View the notification here:https://www.nemko.com/hubfs/Nemko%20USA/2026-10-16_HDD%20extension%20to%202027-05-01.pdf

19/10/2026

The regulatory landscape for AI is evolving quickly.

Join us on October 28 at 11:00 AM EST for a webinar on the EU AI Act: Latest Changes & Updates. We'll cover the latest developments, compliance requirements, risk classifications, and implementation timelines that organizations need to know.

Whether you're developing AI-enabled products, managing compliance, or navigating market access requirements, this session will help you understand what's changing and how to prepare.

📅 October 28, 2026
🕚 11:00 AM EST

🔗 Register today: https://www.nemko.com/eu-ai-act-updates-webinar-2026

Adresse

2210 Faraday Avenue Ste 150
Lysaker
92008

Åpningstider

Mandag	08:00 - 17:00
Tirsdag	08:00 - 17:00
Onsdag	08:00 - 17:00
Torsdag	08:00 - 17:00
Fredag	08:00 - 17:00

Telefon

+4722960330

Nettsted

http://linktr.ee/nemko.group

Varslinger

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