CAPA under scrutiny
Regulators and notified bodies examine whether CAPAs address root causes and are verified effective.
medical device QMS software
Quality management software for medical device manufacturers
Medical device manufacturers need disciplined CAPA, complaint handling and traceability. QCIN connects these processes, while being transparent about what a regulated QMS still needs beyond it.
Medical devices quality challenges
Complaint handling
Every complaint must be recorded, investigated and linked to affected product.
Lot-level traceability
Manufacturers must quickly identify every lot built from a suspect component.
How QCIN supports medical devices teams
CAPA with effectiveness checks
Root cause tools and an optional gate requiring effectiveness verification before closure.
Complaint handling
Complaints linked to lots and serials, with RMAs, attachments and customer communication.
Lot traceability
Backward and forward genealogy with downstream hold for containment.
Document control
Approval workflow, version history and per-revision acknowledgment by staff.
Training records
Competency matrix with training records and expiry tracking.
Calibration
Gauge register with due dates, certificates and blocked use when overdue.
What QCIN does not do (yet)
- QCIN is not validated for FDA 21 CFR Part 11; its on-screen signatures are not Part 11-compliant electronic signatures.
- UDI management, design controls / design history files and regulatory adverse-event reporting are not included.
- QCIN is not certified to ISO 13485; computer software validation for your intended use remains your responsibility.
Relevant QCIN modules
Frequently asked questions
Is QCIN validated for FDA 21 CFR Part 11?
No. QCIN is not Part 11 validated. If your processes require Part 11-compliant electronic records and signatures, QCIN should not be your system of record for them.
Can QCIN support an ISO 13485 QMS?
QCIN covers processes such as CAPA, complaint handling, document control, training, calibration and traceability, but it is not ISO 13485 certified and you must validate it for your intended use.
Does QCIN manage UDI?
No, UDI assignment and database submission are not part of QCIN.
Can complaints trigger CAPA?
Yes. A complaint can raise a linked NCR/CAPA so the investigation keeps the lot and customer context.
Run a medical devices quality pilot in QCIN.
Start a free 14-day trial — no card required — or book a walkthrough with our team.