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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