/ In Vitro Diagnostics
In Vitro Diagnostics
EU IVDR 2017/746
EU IVDR 2017/746, ISO 13485, and CLSI EP09. The IVDR gate family is defined and ready for engagement.
THE PROVING GROUND
See the gate run on a neighboring artifact. Every part that passes carries the same verified thread.
Where the part lives or dies.
EU IVDR 2017/746 requires a dedicated technical file and performance evaluation for every IVD device, distinct from MDR. Class C and D devices demand notified-body involvement, analytical performance studies, and clinical evidence assembled before the conformity assessment window opens. One missing performance study and the CE mark does not issue.
WHAT THE GATE RECOVERS
60 to 300 hrs
Labour a single submission consumes. About half recovered per verified package.
Toward 95%
First-pass approval rate. Production agents score the full package before it leaves your desk.
Weeks back
Per submission, recovered from review loops and re-test cycles avoided.
1 to millions
Each verified submission authorizes the parts that follow.
Roadmap
Use cases this sector displaces.
- Assembling IVDR technical files from analytical and clinical performance study records
- Cross-checking performance evaluation reports against IVDR Annex XIII requirements
- Tracking notified-body correspondence and audit trail for Class C and D devices
- Flagging technical file gaps before conformity assessment submission
START HERE
Bring one part. We run it through the gate.
Declare your part and its submission intent. We run it through the Submission Gate and hand back the verdict and the certificate. One part. One pass. Everything cited.
Today we define the IVDR gate. Tomorrow we carry the technical file to the notified body.