Welcome to our Crowdfunding Proposal for the Process Record Slide (PRS) to be FDA registered. The PRS is a must-have product for all pathology laboratories as specified by the World Health Organization (WHO) quality guidelines.
We are looking to raise the following amount:
GOAL: USD250k – 5000 trials @ USD 5 for each trial (10 pcs)
Patents: 6 Patents filed
Clinical Information: Medical device
Regulatory Status: FDA class 1 filed as slide to slide calibrator
The purpose of this crowdfunding is to raise funds for support from the pre-selling of the product. We also seek agreement from the circle of pathologists and professional in the field that our product is indeed the vital missing link in their IHC process.
We don’t provide equity for the money received but will exchange the product to trial.
PRS was released by Process Record Slide Limited based in Hong Kong.
We provide a must-have solution for laboratories, hospitals and pathologists with our new PRS product.
There is an urgent need to fill the gap when it comes to the elusive missing-link within the global laboratory quality system.
With our company’s creation of the innovative Process Record Slide (PRS) we are able to meet that need in a very precise and exacting way.
The Process Record Slide (PRS) is a must-have FDA registered medical device that aids pre-screening by lab technicians and pathologist diagnostic interpretation efforts.
The PRS will:
For a long time, colleges of pathology and government FDAs have been calling for independent real-time control for each staining process but this has never been possible until today with the new PRS product. Government FDA and colleges of pathology across the world have sought QC and process tracking information for the medical stain processing activities. Some have gone so far as to have the requirements already documented for the time when such technology should become viable and cost effective. The waiting is over as the PRS addresses the needs on all fronts.
We strongly recommend that all laboratories consider using PRS for their biopsy staining process particularly in view of the fact that WHO states this quality control component is an essential element. By including this, the laboratory will be provided with authority, conviction and confidence in being able to prove that the test results are accurate and reliable prior to the patient results being created.
We strongly recommend that all laboratories consider using PRS for their IHC biopsy staining process particularly in view of the fact that WHO states this quality control component is an essential element. By including this, the laboratory can confirm the efficacy of reagents used, tissue handling, and process control of the patient sample through the IHC processing. Thus, the laboratory can document that its processing of the biopsy sample is valid prior to the diagnostic interpretation being performed. Of course, the biopsy may not contain any of the sought for conditions and the outcome would be a true negative result.
Disclaimer: Although we expect our product will be launched in September or October in 2017, the purchaser may expect delay or even non-delivery of the product.
