SOFTWARE FOR THE MEDICAL DEVICE INDUSTRY
EVERY BATCH. EVERY DEVICE. ONE RECORD.
Epsilon3 runs the build, inspection, and validation procedures that get medical devices from the cleanroom to the patient — every step, signature, and deviation captured as it happens, ready for the audit before the audit ever shows up.
TRUSTED BY THE MOST CONSEQUENTIAL PROGRAMS
WHY MEDTECH TEAMS CHOOSE EPSILON3
PURPOSE-BUILT FOR HOW A DEVICE ACTUALLY EARNS ITS DHR.
A paper batch record and a spreadsheet CAPA log weren’t built for a device that has to be traceable down to the unit, not the lot. Epsilon3 was.
Build & inspection execution
EVERY STEP OF THE DHR, SIGNED AS IT HAPPENS.
Run assembly and inspection procedures from one system, with pass/fail criteria evaluated against the measurement as the operator takes it — so the device history record is complete the moment the unit is, not reconstructed at batch release.
20x FASTER THAN PAPER BATCH RECORDS
Cleared before you evaluate
RECORDS ALIGNED TO 21 CFR PART 820 & ISO 13485.
Output structured to satisfy 21 CFR Part 820 annd ISO 13485 documentation requirements, with SOC 2 Type II secured and FedRAMP High available for federal and VA-adjacent programs — the posture your auditors already expect.
AUDIT READY, BY DEFAULT
Design controls & V&V
VERIFICATION EVIDENCE, TIED TO THE REQUIREMENT IT PROVES.
IQ/OQ/PQ and V&V test execution captured against the specific requirement each test point verifies — so your design history file builds itself as the test program runs, not weeks later from someone’s notebook.
EVERY TEST POINT TRACEABLE, BY DESIGN
Traceability & CAPA
DOWN TO THE UNIT, NOT JUST THE LOT.
Lot and serial genealogy follow the device from incoming material to shipped unit, with every CAPA tied to the exact step, operator, and device that produced it — so a field issue traces to the units actually affected.
ONE RECORD, NOT FIVE SYSTEMS
MEASURED ON REAL PROGRAMS
—
98%
fewer execution errors versus paper batch records
—
20x
faster execution than paper-based DHRs
—
50%
faster batch release cycle time
—
100+
device build & validation programs run through Epsilon3
SOFTWARE FOR DEVICES THAT SIMPLY CANNOT FAIL.
BRING A BATCH RECORD YOU ACTUALLY RUN. WE’LL SHOW YOU IT WORKING IN THAT.
REQUEST A DEMO
SEE THE SYSTEM RUNNING ON A DEVICE YOURS.
A 30-minute walkthrough tailored to your program — production, V&V, or full device lifecycle. Not slides. The system in prod.
A real DHR or batch record running in real device operations
Your integrations — PLM, ERP, quality management system (QMS)
Records aligned to 21 CFR Part 820 & ISO 13485, FedRAMP High available
Configuration, not customization — no consultants required