Enable Innovations’ Quality Management System is ISO 13485:2021 certified. The production plant is designed and operated according to GMP. Recently, Enable Innovations also obtained authorisation for the production and filling of food supplements and food for special medical purposes (AFMS) in liquid form.
EU Quality Management System Certificate according to EU Regulation 2017/745
Full Quality Assurance System approval according to European Directive 93/42/EEC
The maintenance of high quality standards within Enable Innovations is ensured by the quality team, which, with the help of various highly qualified figures, guarantees compliance with the requirements of the particular regulatory framework.
ISO 13485 certification, the presence of production environments monitored according to GMP and compliance with internal procedures ensure constant control of all the stages involved in the production of the medical device, from design to industrialisation.
The presence of a chemical-physical laboratory and a microbiological laboratory within the company, equipped with state-of-the-art instrumentation and managed by qualified personnel, makes quality a strong point at Enable Innovations, ensuring optimal control over the entire production chain: from raw materials to the finished product.
Our highly specialised team is able to design, develop, optimise, validate and apply new chemical-physical and microbiological analytical methods for the control of products and raw materials.