Medical Devices Directive

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Machinery Directive 2006/42/EC EMC Directive 2014/30/EU Low Voltage Directive 2014/35/EU Imported Equipment Medical Devices Directive 93/42/EEC R&TTE Directive 2014/53/EU Reliability MTBF calculations Safety Testing. EMC. Reliability

Medical Devices and EN 60601-1 Medical Devices Safety

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.

A Risk Management File complying with ISO 14971 is needed to satisfy EN 60601-1 in many places. When Medical Devices are submitted to a Notified Body, a Risk Management File forms an integral part of the documentation package. In this area too we can provide practical assistance in preparation for a successful submission, and full compliance with 93/42/EEC - The Medical Devices Directive.

If you require assistance with the Medical Devices Directive and EN 61010-1 compliance, or with compiling a Risk Management File to ISO 14971 - please contact us directly on the numbers below.

E-mail or telephone +44 (0)1782 479 230

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