Qualification Planning and Testing

Qualification Planning and Testing

Qualification Planning and Testing requires coordination of the development of protocols with product claims, risk mitigation and performance requirements. Qualification planning pulls together Design Control compliance, regulatory submission requirements, such as development of claims, indication for use and labeling and scientific methods to develop the evidence of Substantial Equivalence and Safety.

Paladin Medical® can help you identify qualified labs and assist your engineering team in the establishment of outcome measures and acceptance criteria. Test articles for qualification testing require characterization prior to testing. We can help you assure you have established and full understanding of the product prior to launching expensive testing.