Nemko

Nemko Companies around the world trust Nemko to assess their products, systems, installations and personnel for conformity with relevant standards and regulations.

Since 1933, we have ensured that our customers comply with requirements anywhere in the world.

When transitioning to a new safety standard, it’s important to look beyond the end product itself. Critical components, ...
02/09/2026

When transitioning to a new safety standard, it’s important to look beyond the end product itself. Critical components, such as power supplies, may also need to meet the applicable requirements of the new standard.

This week’s question focuses on the transition to IS/IEC 62368-1:2023 and what manufacturers need to know when their existing power supply certification is based on an earlier standard.

Understanding critical component requirements early can help you plan testing more efficiently and avoid unexpected delays during the registration process.

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

Submit your question for a future Ask a Nemko Expert post: https://www.nemko.com/ask-a-nemko-expert

Effective August 5, 2026, CNCA suspended CCC-designated certification bodies from commissioning U.S.-based certification...
28/08/2026

Effective August 5, 2026, CNCA suspended CCC-designated certification bodies from commissioning U.S.-based certification bodies to conduct post-certification factory inspections.

If you manufacture CCC-certified products in the U.S., this could affect upcoming inspections, scheduling, costs, and certificate status.

And this may not be the last regulatory change to watch.

Join Vanessa Wen at Nemko’s Regulatory Conference Livestream, September 23–24, for the latest updates on China’s safety, EMC, and wireless requirements.

Have questions about China compliance? Join us and Ask a Nemko Expert.

Register here: https://www.nemko.com/2026-global-regulatory-conference

Need a field evaluation but not sure what to expect? Our Field Evaluations 101: What You Need to Know webinar is tomorro...
26/08/2026

Need a field evaluation but not sure what to expect? Our Field Evaluations 101: What You Need to Know webinar is tomorrow, August 27 at 2 PM EST.

We’ll break down the field evaluation process in straightforward terms from why equipment may be rejected by an inspector or AHJ to what happens during the evaluation, what documentation is needed, and how field labeling and the final report complete the process.

If you’re dealing with newly installed, imported, custom-built, or modified equipment, this is a practical introduction to help you understand your next steps.

Join us tomorrow and get the answers you need to move your equipment toward approval.

Register now: https://www.nemko.com/understanding-field-evaluations-getting-started-webinar-2026

🔎 Ask a Nemko ExpertStandards can vary from one market to the next and knowing which edition applies before testing begi...
26/08/2026

🔎 Ask a Nemko Expert

Standards can vary from one market to the next and knowing which edition applies before testing begins can help you avoid unnecessary retesting, costs, and delays.

This week’s Ask a Nemko Expert takes a closer look at IEC 62368-1 and why your target markets matter when determining which edition to use.

Have a compliance question you’d like our experts to answer? Submit your question through our Ask a Nemko Expert series. https://www.nemko.com/ask-a-nemko-expert

With the FDA’s Quality Management System Regulation (QMSR) now effective, medical device companies are taking a closer l...
24/08/2026

With the FDA’s Quality Management System Regulation (QMSR) now effective, medical device companies are taking a closer look at how their quality systems align with ISO 13485:2016.

ISO 13485 provides a framework for managing critical processes across the medical device lifecycle, from design and development and supplier management to risk management, traceability, complaint handling, and corrective actions.

For organizations preparing for certification, customer audits, or changing regulatory expectations, a gap analysis can help identify areas that may need attention before they become bigger challenges.

Consider asking:
• Are your customers requiring ISO 13485 certification?
• Are you prepared for FDA QMSR expectations?
• Are there gaps in your supplier controls, risk management, CAPA, or traceability processes?
• Would a gap analysis help you better understand where your quality system stands?

Nemko supports medical device organizations with ISO 13485 certification and gap analysis services to help strengthen quality systems and support confidence throughout the supply chain.

Interested in ISO 13485 certification or a gap analysis? Contact us to discuss your organization’s needs and connect with our team. https://www.nemko.com/start-your-iso-certification-journey-nemko-management-system-certification

Has an electrical inspector told you your equipment isn’t approved for installation?If you’re facing a field evaluation ...
21/08/2026

Has an electrical inspector told you your equipment isn’t approved for installation?

If you’re facing a field evaluation for the first time, knowing what to expect can make the process much easier.

Join us for Field Evaluations 101: What You Need to Know on August 27 at 2 PM EST. We’ll walk through the field evaluation process from start to finish, including why evaluations are required, what engineers look for, how AHJs and NRTLs fit into the process, and what happens when compliance issues are identified.

Whether you’re dealing with a newly installed machine, imported equipment, a custom-built system, or modified machinery, this webinar will help you understand the path from inspection to approval.

Don’t know where to start? Start here.

👉 Register for the free webinar: https://www.nemko.com/understanding-field-evaluations-getting-started-webinar-2026

The withdrawal raises important questions for companies selling into Europe—particularly around presumption of conformit...
21/08/2026

The withdrawal raises important questions for companies selling into Europe—particularly around presumption of conformity, the EU Official Journal, and the transition to newer editions of the standard.

And with IEC 62368-1 4th Edition already here, manufacturers also need to understand where it has been adopted, which markets accept it, and when they should begin transitioning their testing and certification programs.

Join Nemko’s Live Regulatory Conference for an in-depth look at the latest EN/IEC 62368-1 developments, including:

• What the withdrawal of EN 62368-1:2014 means for EU compliance
• Presumption of conformity and the EU Official Journal
• EN IEC 62368-1:2024 and IEC 62368-1 4th Edition
• Country-by-country adoption and acceptance
• Key transition considerations for testing and certification

Don’t let a standards transition catch you off guard. Join us to understand what’s changing and how to plan ahead.

👉 Register for the livestream: https://nemko.spiffy.co/checkout/2026-nemko-global-regulatory-conference-livestream-registration

Ask a Nemko Expert 💡Can one EMC test support compliance in multiple countries? In many cases, yes, but it all comes down...
19/08/2026

Ask a Nemko Expert 💡

Can one EMC test support compliance in multiple countries? In many cases, yes, but it all comes down to planning.

In this week’s Ask a Nemko Expert, James Cunningham, Nemko San Diego EMC/Wireless Manager, explains how a well-planned EMC test strategy can help reduce duplicate testing, lower compliance costs, and shorten time to market.

The key? Know your target markets before testing begins and work with a laboratory that understands the requirements across regions.

Have a compliance question you’d like our experts to answer? Submit your question through our Ask a Nemko Expert series. https://www.nemko.com/ask-a-nemko-expert

You have compliance questions. Our experts have answers.We’re excited to launch Ask a Nemko Expert, a new weekly series ...
17/08/2026

You have compliance questions. Our experts have answers.

We’re excited to launch Ask a Nemko Expert, a new weekly series where we’ll tackle real questions about product compliance, testing, certification, and global market access.

From EMC and Safety to RF/Radio, Cybersecurity, HazLoc, Field Evaluation, and Global Market Access, we’ll bring answers straight from the Nemko experts who work with these challenges every day.

And now, we want to hear from you! What compliance question would you ask a Nemko expert?

Submit your question for a chance to have it answered on social media: https://www.nemko.com/compliance-questions-answered-ask-a-nemko-expert-series

No question is too simple or too technical.

A big thank you to everyone who joined us for our ribbon cutting ceremony yesterday, and a special thank you to the Hutt...
11/08/2026

A big thank you to everyone who joined us for our ribbon cutting ceremony yesterday, and a special thank you to the Hutto Chamber of Commerce for helping us celebrate this exciting milestone.

We’re proud to be part of the Round Rock/Hutto community and look forward to continuing to grow our presence in the area while supporting our customers with testing, inspection, and certification services.

Thank you to everyone who came out, connected with our team, and helped make the day special. We’re excited for what’s ahead!

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