Our engineers and technicians deliver support services within qualification and validation of production processes. As a leading developer of automated production processes, with an in-depth understanding of GMP, ISO 13485  and GAMP5, the AP team is well suited to make a difference in your Medtech project.

We can join customer project teams as members for shorter or longer periods of time, or we can be assigned to deliver specific QA tasks.

  • Developing technical documentation and test protocols (SAT, FAT plans)
  • Risk analysis and CE-marking
  • Review, analysis, and re-qualification of processes in order to improve and stabilize production
  • Developing URS (User Requirements Specification) for customers investment projects
  • Review of implemented QA control methods; validate or test?

Quality Assurance

  • Design robustness
  • DFM/DFA analysis
  • Review of key processes and critical technologies

Test documentation

  • FAT – Plan, Perform and document
  • SAT – Plan, Perform and document
  • IQ & OQ – Plan, Perform and document