Rely on our reputation, accreditation and guarantee

As your Quality Assurance partner, NewTech Dental understands your requirement for certainty of delivery and superior product manufacture.

Our manufacturing process adopts the following principles.

Accreditation

Exceptional manufacturing starts with a comprehensive quality management system, the implementation of which builds the foundation of the supply of a world class product. We are proud to have 3rd party accreditation of both ISO 9001 and ISO 13485.

The ISO 9001 accreditation proves we adhere to required standards, developed and published by the International Organization for Standardization (ISO). These define, establish and maintain an effective quality assurance system for manufacturing industries.

ISO 13485 is a standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

We comply with both these standards, maintained on an annual basis with site visits by an accredited QA consultancy.

We also have CE certification of all materials that we use in the manufacturing process.

Supplying to the German, Swedish and French markets requires us to comply with European standards (EC), FDA standards in the US, TGA standards in Australia and GDC standards in the UK.

In Australia a manufacturer of custom made medical devices is not required to include the items on the Australian Register of Therapeutic Goods (ARTG). However it is necessary for the manufacturer to comply with the applicable provisions of the TGA’s essential manufacturing principles checklist and this is a criteria that we do meet.

Product Guarantee

We recognise that in the real world, problems can occasionally arise with individual patient devices. NewTech Dental’s commitment to you involves resolution of any problem, however slight, at no cost to you. We will undertake to rectify any manufacturing defects with a replacement dental appliance.