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

For more information on IEC 60601 Guidance talk to Cranage Veritas