Healthcare Innovation Cycle for "IVD" Solutions

In vitro diagnostics (IVDs) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases. Tracking data has been added to show an example of an early stage team at risk due to a focus on technology. Select any Maturity Level to see the core Requirements or select the Requirements themselves to see a description of what is involved in completing a requirement and curated resources.

Note:To access the Resources that describe each Deliverable, use the Sign-in button above to create an account and then click on the Deliverable or the Innovation Maturity Level to see all Deliverables at that level and click on the one of interest.

Download a complete 
checklist.

Note: Download and open the PDF so that it is fiilable

MaturityDisplay

Requirement

Design Control System In Place

Part of an organization's overall the Quality System that are required for medical devices under design control are: "User Needs", "Design Requirements", Validation Requirements", "Verification Requirements", "Design Inputs", "Design Outputs", "Risk Analysis"
Required for the approval of medical products and the sooner a system is implemented the less risk and rework is required
There are many approaches as outlined in the Resources below. Suggest considering hiring a consultant that has actually set up a quality system or work within such a system for a few years. Lots of details here that will kill an innovator mentally!

CategoryFiltersPortlet

Resource Type
Regions/Markets