Index Products Products new dev Products-Joystick Products-Switched Clinical Engineering Regulatory About me Links PS3-SAP TSP Kick Switch ARM Strafe Switch Orthros TAS Tilt Angle Sensor Game Case SAP-4SAPA Serv Phil Serv Aims Assm Meth App Tech Projects App Tech - Table EMC Electronic des Func Prod Des Custom modules Custom GCC MDD 60601 Custom Made Dev SAP-JAW SAP-JAS Custom Made DevMedical Devices Directive BSEN 60601-1 Custom Made Devices Regulatory Consultancy The key to being able to undertake some of these challanges safely and in compliance with relevent standards is an understanding of the regulatory framework around Medical Devices and their manufacture and management.The Medical Devices Directive, 93/42/EEC is the key to these activities. Although not containing any specific technical information regarding products, it clearly lays out the procedures that must be used when designing, manufacturing and marketing these devices. Along side this is the Vigelance procedures that define how you should manage the process when things go wrong! My consultancy input usually revolves around providing support to the documentation process of new products such as what kind of documentation is required and how do I store it and access it in a logical and efficient way.So, if you need advice from someone who has been there and has the T shirt, get in touch !E-mail:Phone: 0771 495 8061 Geoff@LEPMIS.co.uk BACK Long Eaton Powered Mobility Integration Service Unique Solutions For Unique PeopleIntegrated Systems for an Integrated Lifestyle An independent clinical assessment and engineering service for persons with moderate to severe disability who require specialised adaptations in order to access powered wheelchair mobility, computer game console or other assistive technology Products Home Clinical Assessment Services Regulatory /Consultancy Engineering Design and Manufacture Links About / Contact Us To see all content, you will need the current version of Adobe Flash Player to view it. |