Standards Advisory Service
- SAS
Simple And Straightforward
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We help you select the standards applicable
to your devices. - A pro- active regulatory service
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One of our experienced Technical Specialists
will be appointed to take personal care of your requirements. - A
highly skilled & personal service
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We provide quarterly updates of any
amendments, new versions or new applicable standards relevant to your devices.
- Maintaining your Global Regulatory Compliance
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We provide guidance on the changes
you may need to make to your Quality Management System or technical documentation.
- Maintaining your Quality Management System
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On subscribing to SAS you will receive
our SOP template on Standards Review to incorporate into your QMS.
- Introducing Best Global Practice into your Business
What to do:
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Send one copy of each of your Declaration
of Conformity/s for your devices, including the product schedule, attach
a list of the Standards complied with by device. Also include the list
of standards that your Quality Management System has adopted. If you have
grouped your devices into *Families prepare your listing by the Device
Families - Use our listing sheet for speed & ease.
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We will review your listing to determine
if there are other standards that you may wish to comply with.
APPENDIX 1
STANDARDS, REGULATIONS, EUROPEAN
DIRECTIVES AND OTHER DOCUMENTS FORM
Device Name
or QMS |
Title |
Standards Ref |
Date |
Comments |
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Signed:__________________________
Date:___________
Name:___________________________
Title:___________
Company Name:___________________________________
Company Address:__________________________________
_________________________________________________
Zip Code:____________
Tel:_________________________Ext:____
Fax:______________________________
| Costs |
Number of device families |
| £ 255 or US
$ 400 per Quarter |
1 to 9 |
| £ 375 or US
$ 600 per Quarter |
10 to 19 |
| £ 575 or US
$ 920 per Quarter |
20 to 49 |
| £ 755 or US
$ 1200 per Quarter |
50 to 74 |
| £ 1050 or US $ 1680 per
Quarter |
75 to 99 (over 100 prices
on application) |
To join our pro-active Standards
Advisory Service email or fax the above list of your device families &
remember to attach your Declarations of Conformity.
M.Devices Ltd Fax: +44 170 45
44 40 50 From USA 011 44 170 45 44 40 50
* Definition of a Device
Family:
- a grouping of related
devices, device types or models, which share a high degree of identical
technologies, quality characteristics, design, construction and/or intended
applications.