ISO 13485 supercedes EN46001 for Medical Devices.

In essence the procedure for certification is the same as that for ISO 9001 (as this scheme is based on the prime document ISO 9001). However, there are some key differences regarding the certification process.


ISO 13485 Certification

The minimum audit day requirements are more onerous due to the additional documentation to be checked.


Cost of ISO 13485

Individual quotations will be given free of charge on a case by case basis.

For further details please contact your local URS office

NB
Taxes are required in the UK @ 17.5% VAT.
In some cases local travel and accommodation expenses will be levied e.g. USA.