Ukca Self Declaration Template - Quality management system assurance [annex ix] followed by assessment of technical documentation per generic device. Genetic tests, companion diagnostics, blood gas analyzers, caner markers, rubella, neonatal screening for metabolic disorders etc. As per ivdr classification for class c ivds, ce mark could be achieved through the conformity assessment routes:.
Quality management system assurance [annex ix] followed by assessment of technical documentation per generic device. Genetic tests, companion diagnostics, blood gas analyzers, caner markers, rubella, neonatal screening for metabolic disorders etc. As per ivdr classification for class c ivds, ce mark could be achieved through the conformity assessment routes:.
