How we work

Medical Devices Manufacturing

ALMA Medical Devices are developed by our own R&D Lab and manufactured exclusively in our Italian factory, assuring the full flow traceability and the highest quality standards for the entire supply chain.
Production, filling and packing take place in Alma’s plant. A clean room is dedicated to the filling process.
We manage the industrial transfer and scale up and the Manufacturing process according to ISO13485: 2012 Medical devices - Quality management systems.

Certifications

Medical devices - Quality management systems (ISO13485: 2012)
Our cutting-edge manufacturing plant obtained different Certifications:

  • Quality Management System Certification (ISO9001)
  • Certification for the Good Manufacturing Practices (GMP) of Cosmetic Products (ISO22716)
  • Environnemental management system Certification (ISO14001
  • Occupational Health and Safety Management System (OHSAS 18001)

Quality control

Internal Quality Control & Microbiology Lab: the production and packaging of any type of cosmetic and medical device satisfy the most severe GMP.
The internal Quality Control Lab is responsible for monitoring of the entire production cycle: it deals with sampling and controls of incoming materials, it verifies the compliance of the semi-finished products and process water, it carries on “in-process” controls and compliance tests on the finished products. The internal Microbiology Laboratory ensures a maximum level of microbiological safety.