Quality
Quality Assurance Function
The Quality Assurance System applies to all activities of the company and combines a responsible management structure. This defined set of processes and procedures ensure that the requirements of the customer are satisfied. The quality management system is also designed to meet or exceed the requirements of the ISO 9001:2000 and ISO 13485:2003.
Products are manufactured in accordance with the appropriate standards and are CE marked in accordance with the Medical Devices Directive 93/42/EEC.
The quality management system is certified by Nordic Dental Certification, Norway and is reviewed on an annual basis.
Regulatory Affairs
Over the past several years we have dealt with product registration in different countries all over the world. We liase with our customers in order to obtain information on all the relevant laws and regulations as well as providing documents necessary for company and product registration, which are applicable in various countries.
We ensure that the product which is to be placed on the market complies with the regulatory requirements in each individual market. Documents such as “Free sales certificate”, “Declaration of conformity” and “Certificate of analysis” are available upon request for both potential and existing distributors.
Clinical Studies
We currently have a limited number of clinical studies that are available at the moment, but more are scheduled and in progress for the future. These have been carried out in order to obtain objective information about the clinical performance and the quality of our products. The importance of evaluating our products to obtain as much information as possible is a key point in our continued progress and development which may provide information about areas that could be improved. The results of these clinical studies can substantiate our claims and in turn contribute to ongoing development in the field.
Complaint Process
It is essential to us that we have a complaint process in place that is easily understood by our customers. It is our aim to provide both the best products and services to our customers and therefore appreciate feedback regarding any such complaints or indifferences in product standards that may arise. This gives us the possibility to tackle the issue immediately and prevent future complaints, while in turn assuring that this problem will not occur again in the future.