Services 2021-06-28T09:59:41+00:00

Quality assurance and quality control

The maintenance of high qualitative standards is assured by the quality team that is composed of high qualified personnel, guaranteeing the compliance with the requirements of the regulatory framework of reference.

The certification ISO 13485, production areas monitored according to GMP and the observation of the internal procedures allow to guarantee the constant control of every single phase involved in the production of the medical device, starting from the design to the industrialization of the product.

The presence inside our company of a chemical-physical and a microbiological laboratory, equipped with the most innovative instrumentation and managed by qualified personnel, makes quality a strong point of Enable Innovations assuring an optimal control over the whole production chain: from raw materials to the finished product.

Our highly specialized team is able to design, develop, optimize, validate and apply new chemical-physical and microbiological analytical methods for products and raw materials inspection.

The services the Quality team can offer are:

  • Chemical-physical and microbiological analysis of raw materials, semi-finished and finished products;
  • Development and optimization of chemical-physical and microbiological analytical methods of raw materials, semi-finished and finished products;
  • Analytical methods validation;
  • Aseptic production processes validation;
  • Planning and performance of sterilization process validation activities through primary packages irradiation;
  • Performance of microbiological analysis in aseptic environment;
  • Design and performance of stability tests in compliance with ICH regulations, for various temperature and humidity conditions;
  • Design and performance of in-use stability tests;
  • Design and performance of on-going stability tests in compliance with GMP;
  • Customers support for drafting and updating of protocols, procedures, QTA, change, etc.;
  • Contacts management, on behalf of customer, with external laboratories for the execution of targeted analysis.