Qualification
Plan and execute performance studies with least burdensome methods.
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.
Verification and Validation is the bedrock of swift pre-market submission. Approval depends upon evidence that the device has been qualified to meet the requirements set forth in the design and quality plan, including compliance with international standards and FDA guidance. Examples of evidence development include:
- Sterilization and packaging validation
- Software and hardware validation
- Bench top and animal testing Read More in Preclinical Study Design
- Shelf-life and durability testing
- Electronic safety testing (EMC and coexistence)
- Biocompatibility Read More about Biocompatibility and Biomaterials in SPECIALTY SERVICES
Some devices require animal and clinical studies Read more in Preclinical/Clinical but many now also require Human Factors or Usability Testing. Paladin Medical® provides services at all levels of user study planning, management, and field monitoring. Read more about Human Factors and Usability Studies in SPECIALTY SERVICES
Qualification Planning depends upon a comprehensive Hazard Analysis and Risk Management program compliant with ISO 14971. We help your team identify requirements for the product, identify hazards which may be associated with potential failure to meet those requirements, potential cause and effect and potential methods for mitigation of those hazards. Assessment of potential for Harm, Frequency and Detectability help to define qualification and testing required. Review Read more about Risk Management in SPECIALTY SERVICES.
