Medical

Free to download
£ 250.00 each

Self-Assessment Procedure for Class 1 Medical Devices V3 Includes 2 Hrs Consultancy

This downloadable pack contains the information required for you to understand the process of CE marking Class 1 Medical Devices.

£ 500.00 each

Own Brand Labelling for Medical Devices

1st April 2017 - This product is currently under review, in order to be aligned with the MHRA guidance "Virtual Manufacturing replaces Own Brand Labelling for medical device manufacturers" Version 1.0 March 2017. To view this document please click here. For more information please contact us. 

£ 10.00 each

Draft Declaration of Conformity for Class I Medical Devices

This draft Declaration of Conformity is suitable for non-electrical Class I medical devices. It is an editable document and comes complete with detailed guidance notes.

£ 10.00 each

Draft Declaration of Conformity for Class I Medical Devices which contain Electrical Equipment

This draft Declaration of Conformity is suitable for Class I medical devices that contain electrical equipment and are therefore also within the scope of the Restriction of Hazardous Substances Directive (RoHS2).  

£ 25.00 each

Medical Devices Directive Classification Guide

Medical devices fall into one of four (Class I, Class IIa, Class IIb and Class III) categories depending on the level of risk.

£ 20.00 each

Technical File contents checklist for Medical Devices Directive

Technical file contents checklist for the Medical Devices Directive.

£ 130.00 each

Prepaid Consultancy Time- 60 minutes

60 minutes consultancy time  - Speak to one of our expert engineers without the need to set up commercial arrangements. Please inform us of your time constraints when ordering this service and we will endeavour to meet them.

£ 70.00 each

Prepaid Consultancy Time - 30 minutes

30 minutes consultancy time - Speak to one of our expert engineers without the need to set up commercial arrangements. Please inform us of your time constraints when ordering this service and we will endeavour to meet them.

£ 25.00 each

Medical Device Directive Logos Package V3

This downloadable pack contains all the logos you will need to deliver information and Instruction to the user of your Medical Device. It also Contains checklists to help you identify the symbols you require.

 

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Conformance Offices

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UK

Great Hucklow
Buxton
Derby
SK17 8RG
England

Tel: +44 (0)1298 873800
Fax: +44 (0)1298 873801
E-mail: cemark[at]conformance.co.uk

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China

Room 601, Building 13, Jinwai SOHO
Chaoyang District
Beijing
1000022
P.R. China

Tel: +86 (0)10 5702 3959


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