Interested in having your product CE marked or FDA Approved?
Outsource Verification & Validation of your Immunoassay or Molecular Test to Future Diagnostics
Verification and validation (V&V) are critical phases in the completion of your Design History File. The Design History File is part of the technical file and above all necessary to have your product FDA registered or CE marked. We avoid delay in your product launches, because we know what we are doing. In other words, how frustrated can it be if you misinterpreted the guidelines for any documentation needed. The Food and Drug Administration (FDA) and EU Directive 98/79/EC set the recommendations for all steps in the manufacturing procedures. They have the authority and responsibility to perform inspections and audits in regards to the V&V process which is performed by the manufacturer. Our Quality Control and Assurance follow strict procedures based on the ISO13485 and FDA standards.
Verification of your Assay
Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.*
Validation of your Assay
Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.*
Verification: does the design meet the design input?
Our R&D produces and releases the verification lots. At the same time the staff from manufacturing is involved. We start with the verification studies and stability studies after successful production of the lots. R&D transfers the production processes to the manufacturing site in the meantime.
The following steps are followed in validation studies:
Dedicated teams carry out experiments to validate produced lots. Secondly, we verify that the validation lots comply with the design requirements mentioned in the product specification form. The final manufacturing site produces the validation lots according to regulatory- and safety requirements. Our development technician and development experts process all data. The validation report is written afterwards. The outcome of the validation studies can/will be used to support the label claims. They are furthermore used as performance characteristics in the Instruction For Use (IFU).
Henceforth our teams verify that the validation lots show satisfactory results when the tests are performed in an end-user environment. We use routine clinical samples, including samples with extreme values. The customer generally managed the clinical validation at their preferred external clinical trial sites. The owner of the clinical validation writes a report with the clinical validation study results.
We set-up the stability studies with three validation lots as described in the stability plan. The stability studies are designed to meet the stability requirements stated in the design input and in fact compliant with NEN-EN-ISO 23640. Stability studies may run beyond the validation review. Our Technical Architect writes an interim stability report including the results from the stability studies. This report will be updated upon availability of new stability time points.
Advantages to involve Future Diagnostics in performing your V&V work:
- Get your IVD product CE/FDA ready
- Minimal involvement required from your R&D and QA teams
- Work with our dedicated, highly experienced teams
- Confidentiality is guaranteed
- Compliant with NEN-EN 13612 and CLSI guidelines
- If desired transferable to our manufacturing
- Free up your own R&D team to initiate new developments
How we can assist you:
- Write and approve validation protocols, according to regulatory guidelines (i.e. CLSI)
- Perform testing and analyze obtained data
- Write up validation reports
- Completion of the design history file
- Collecting necessary validation samples