Laboratory-Developed Tests & Modified IVD Validation
Don't know how much validation you need?
That's exactly where we can help.
Before investing time and resources in additional testing, speak to us about:
- What you are changing
- Why you are changing it
- How the test will be used
- What evidence you already have
- What evidence you think you need
We'll help you identify an appropriate path forward.
Get the evidence, validation strategy and documentation you need to demonstrate that your test is fit for its intended clinical purpose.
Laboratory-developed tests, modified IVD methods and assays used outside a manufacturer's intended purpose can create complex validation challenges.
You may know exactly how your assay works — but determining what needs to be demonstrated, how much evidence is required and how to document it clearly can be much harder.
Developing or modifying an IVD for clinical use?
ISOCHECKS provides specialist support for laboratories developing, modifying or implementing non-standard diagnostic methods.
Support transition of diagnostic innovations and Laboratory Developed Tests toward clinical use
Experienced professionals dedicated to your success.
Proven results that speak for themselves.
Join us and discover what we can do for you.
