Quality Assurance

Nubenco’s quality systems function as a filter on every level to ensure our products are of excellent quality and exceed the requirements and specifications of our clinets and their regulatory authorities. As an American managed company, we place extreme importance on ensuring all of our products meet the highest and latest standards of quality.

Good Manufacturing Practice (GMP) is the part of quality assurance that ensures products are consistently produced and controlled to the quality standards appropriate for their intended use and as required by the national authority. GMP is aimed primarily at diminishing the risks inherent in pharmaceutical and medical device production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labeling. Above all, Nubenco is most concerned with protecting the end user and avoiding risk due to inadequate safety, quality or efficacy.

Our products each bear the CE mark (European Conformity), meaning that the products are in strict compliance with the EC Directive and therefore can be distributed to each of the countries in the European Union. To obtain the CE mark, Nubenco must hold ISO 9001 and ISO 13485, indicating that the quality management system in place meets strict statuary and regulatory requirements. To ensure the continuous adherence to CE standards, Nubenco regularly receives inspections by TUV.