The core activity of GalloMedic GmbH is to advise and support companies in the medical technology industry in reorienting and planning their businesses, particularly with regard to compliance with regulations such as MDD and MDR. This includes support in planning and implementing new sites, developing products and certifying according to ISO 13485 and MDD/MDR.
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Consulting for repositioning companies, new sites and new products; support from construction through production, and with internal requirements, laws, regulations and standards.
Design, Development and Production Support
Support for design, development, process development, manufacturing and transfer projects for medical devices, production lines and sites.
Quality Management per ISO 13485
Implementation and support of the QM system DIN EN ISO 13485:2016, including the quality manual as well as work and procedure instructions.
Technical Documentation and Development Documentation
Creation of Technical Documentation and the Design History File (DHF), and structured preparation of documents for development and certification purposes.
Validation and Qualification
(Re-)validation and (re-)qualification of processes and methods, including DQ, IQ, OQ, PQ, process characterization and optimization.
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