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IEC 60601 Guidance
At Cranage Veritas, we offer Irish manufacturers a complete range of services to support with IEC 60601 compliance. We can assist with guidance against the MDR EU 2017/745, including testing, guidance and FDA 510(k) submission for the US market. For micro or small manufacturers, we have the authority to act as a Person Responsible for Regulatory Compliance, as outlined in Article 15. Visit our website for complete information on how we can help you achieve compliance for your medical device

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