Medical Devices Directive Enquiries: info@allieda.co.uk Tel: +44 1782 479 230 |
Medical Devices and EN 60601-1 EN 60601-1: 2006 is the technical standard for the safety of medical devices. It consists of a general standard, plus a series of collateral standards and particular requirements. EN 60601-1 has changed considerably in recent years and is now well into its 3rd Edition. Many of the earlier clauses have been modified, and the need for risk management considerably expanded. It is advisable to conduct a general examination against EN 60601-1 at the earliest stage possible. We have the design and manufacturing experience, plus knowledge of the regulatory requirements to save you time and cost. Allied Approvals Ltd is registered in England, Number 6750794.   VAT Registration Number 947 6965 55 |