We have 30 years of experience, across multiple product types, so whether you are an experienced manufacturer with years of product development knowledge, or just starting out- our team can help you.
Our engineers have over 100 years of experience between them, so there isn’t much we haven’t seen, but that alone is not the reason to choose Cranage for your testing requirements.
We specialise in medical product testing and are UKAS accredited for the following main medical standards:
• IEC 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance
• IEC 60601-1-2 EMC disturbances and tests
We also have UKAS accreditation for the following specialist areas of medical device testing:
• IEC 61010-2-101 In-vitro diagnostic (IVD) medical equipment
• IEC 60601-1-11 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
• IEC 60601-2-10 Particular requirements for the safety of nerve and muscle stimulators
Our UKAS accreditation means that we have been assessed by an external auditing body, and our test methods have been certified as consistent and accurate, with a team of impartial and technically competent engineers. This is something we consider particularly important for medical device testing.
Medical device testing is complex and vital to ensure the item operates as it is in intended, without interfering with, or being interfered by, other equipment. We offer pre-compliance testing at the design stage, where our experts will review the design and advise on anything that may cause issues during full compliance testing. This allows the manufacturer to save time and money, as a re-design due to EMC or safety failure further down the production line can prove costly.
The testing of your item is all completed under one roof, meaning it does not need to be moved around and the engineers are all aware of the progress. Cranage is a family run business and we pride ourselves on our service levels. Since being founded 30 years ago, we have continually invested in our facilities and services in order to be able to meet our customer requirements, and our latest extension is due to be finished at the end of this year.
We work with our wholly owned Irish subsidiary, Cranage Veritas, to be able to offer a complete range of product testing, certification and document review for markets around the world, including Europe, America and the Middle East.
If you are planning to sell your product to the American market, we offer a Nationally Recognised Testing Laboratory (NRTL) certification service in the UK, in conjunction with Metlabs. NRTL certification is confirmation that an electrical or electronic product complies with the applicable standards for North America and Cranage are able to offer a complete testing and, under the authority of Metlabs, factory inspection programme.
Cranage Veritas can also offer product risk assessments, Technical File reviews, assistance for compliance against the Medical Device Regulations (MDR) and assistance with preparation for the 510(k) premarket submission to the FDA, which is mandatory for the American market. We use our expertise across our companies to help manufacturers gain global certification.
Visit us at stand B59 to discuss your medical device project and testing requirements with our Operations Director, Jon Jones and Technical Director, Mark Richens.
