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Medical device advisory services

As a Nationally Recognized Testing Laboratory (NRTL), Nemko offers an array of advisory services, ranging from field evaluation services to pre-compliance assistance, through device testing, certification, and approval.

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Organizations across the world trust Nemko to assess their products, systems, and devices for conformity with relevant medical device standards and regulations according to their location.

For more than 85 years, Nemko has ensured that our customers understand and comply with their country’s standards and regulations through the testing, documentation, and successful approval process. We provide services such as pre-compliance, international approval, product and system certifications, and product testing.

Nemko offers local presence powerfully combined with global knowledge.

Helping You Stay One Step Ahead

Your local Nemko team of experts will handle projects through every step of the process and follow up on delivery, keeping your team apprised of any regulatory changes that may occur in the future.

Internationally Recognized AuthorityNemko test reports and certificates are internationally recognized and accepted for national approval processes across the globe. Read More about Internationally Recognized Authority

Test Preparation & PlanningBefore a test can begin, there is a preparation and planning period to establish the testing schedule, which will in turn make sure your tests are performed as efficiently as possible. Read more about Test Preparation & Planning

Safety TestingMedical devices are among the most highly regulated products found in the market today. Make sure your product complies with these standards to ensure the highest level of safety at all times. Read More about Safety Testing

Project Management ExpertiseDuring the testing process, there can be issues that come up and stall the timeline of the project. Nemko offers complete project management expertise to avoid any unnecessary delays. Read More about Project Management Expertise

Electromagnetic Compatibility Testing (EMC)Nemko offers comprehensive global EMC testing and certification services within regulatory requirements for a wide range of electro-medical devices. Read More about EMC Testing

Navigating the Regulatory Maze: 10 Steps to Medical Device Approval

November 9, 2020

// Healthcare & medical devices

Essential Documentation Checklist for Medical Device Approval

February 10, 2021

// Healthcare & medical devices

Successful 2024 KIMES Exhibition Highlights in Seoul

// Healthcare & medical devices

Contact Nemko for advisory services

If you’re not sure where to get started, it’s time to talk to Nemko.

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