Risk evaluation and documentation across all project phases

Launching medical devices requires detailed validation and qualification processes according to European and local regulations and standards such as MPG, IVDR, FDA, GMP and GAMP.

The validation of the methods, processes and procedures is carried out by the customer. During qualification as part of validation, HEKUMA takes over the system approval. We provide and document proof that the system has been designed, installed and tested in accordance with GMP and other required specifications.

The implementation is carried out by means of the following V-model:

HEKUMA core services

  • Risk analysis (FMEA): Identification of the critical functions (GxP relevance) and the scope of qualification based on the customers’ specifications (URS)
  • Design Qualification (DQ): Verification of the correct implementation of the system design to GMP and in accordance with the URS
  • Installation Qualification (IQ): Verification of the correct construction and installation of the system including FAT and SAT acceptance by the customer
  • Operational Qualification (OQ): Checking whether the system is operating according to plan and whether the required proper product quality is guaranteed

HEKUMA additional services

  • Feasibility studies for critical processes
  • Supporting the customer in developing the specifications
  • HEKUMA partner network to further support the customers’ validation effort