Healthcare and medical device compliance made simple
Bringing a new and innovative medical device to market can feel like a complicated and overwhelming process to navigate for any company. That’s why Nemko offers a simple solution.
Testing to Form the Basis for Your Device Certification
See how our dedicated team of experts develop sustainable strategies and offer innovative insights to move your medical device to market in a quick and seamless way.
Nemko test reports and certificates are internationally recognized and accepted for national approval processes across the globe.
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Before 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.
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Medical 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.
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During 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.
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Nemko offers comprehensive global EMC testing and certification services within regulatory requirements for a wide range of electro-medical devices.
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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, ...
Read MoreCollaborative 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.
Robot for hospitalised children gains Nemko certification
A remotely operated robot that becomes the classroom ‘eyes and ears’ of children with long-term illness was developed by the Norwegian company No Isolation, which relied on Nemko for testing, inspection and certification services.
On-demand webinar introduction to requirements for medical devices
By watching the webinar, you will get a better overview of the IEC 60601 series, its constituents and the main elements of risk management under ISO 14971.
