Qualification

Plan and execute qualification performance studies with least burdensome methods.

Qualification Planning and Testing is the culmination of the planning and design that has gone into the development of your medical device. Qualification requires coordination of the intended product claims with risk mitigation, standards compliance, protocol development to substantiate performance requirements.

Qualification Planning depends upon a comprehensive Hazard Analysis and Risk Assessment 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 is the bedrock of planning qualification and testing. Read more about Risk Management in STRATEGIC SERVICES.

Paladin Medical® works with your engineering team to integrate compliance with Design Controls compliance and documentation with requirements for regulatory submission deliverables. We help to assure implementation of scientific methods to develop the evidence of Substantial Equivalence and Safety for performance claims, standards compliance, indication for use and labeling. Characterization of test articles and chain of custody can be required for pre-clinical and other qualification testing. We can help you assure you have established a full understanding of the test article prior to launching expensive testing. See Good Laboratory Practices in Strategic Services.

Verification and Validation is the bedrock for 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
• Electronic safety testing (EMC and coexistence)
• Cybersecurity
• Shelf-life and durability testing
• Bench top and animal testing Read More in Preclinical Study Design
• Human Factors or Usability Testing Read more about Human Factors and Usability Studies in STRATEGIC SERVICES
• Biocompatibility Read More about Biocompatibility and Biomaterials in STRATEGIC SERVICES

 
Some devices require animal and clinical studies Read more in Preclinical/Clinical Study Design 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 STRATEGIC 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. Read more about Risk Management in STRATEGIC SERVICES.

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