Medical Diagnostech’s team of experienced development scientists work will work alongside customers through each stage of the development process, providing updates, advice and joint trouble shooting regarding development of each lateral flow component.
Why use the Medical Diagnostech array of development services?
Phase 3 – Validation
Phase 2 – Optimization
Phase 1 – Feasibility
A development plan to conduct a feasibility study will be prepared based on specifications. At the end of the feasibility study a report will be prepared and submitted along with a small number of early prototypes.
A robust and reproducible test that fulfils the customer specification will be produced. A wide range of materials including membranes, coating buffers, conjugation parameters, buffer release pads and sample pads are evaluated using proven protocols.
The validation stage involves the preparation and submission of a validation plan and the manufacturing of three independent lots using different batches of critical materials. Prior to the validation batches, draft application notes will be prepared and used to conduct the three batch validation.