REGULATORY CONSULTANCY
These days the ever increasing burden of regulatory procedures, directives and standards can make a new or even an existing business struggle to stay compliant. TFT Electronics is familair with all of the regulatory requirements required in today’s electronics and medical devices industry. We can offer on site support and consultation as well as low cost email and telephone support. Whether you just need a part time quality manager, or full quality and regulatory management, we can help train your staff to cope, understand and manage regulatory matters.
We have specialist experience in the following areas:-
The Medical Devices Directive
IEC60601-1 Edition 3
FDA Product Reports & FCC Compliance
510k applications for Medical Devices
The Low Voltage Directive
The EMC Directive
The RoHS Directive
IS09001
IS013485
CE Marking
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