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Ukca Self Declaration Template

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

book2 Stone Compliance Services

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:.