Medical Device Manufacturing Software

FDA-compliant manufacturing ERP for medical devices. DHR management, validation protocols, CAPA tracking, and full audit trails.

Medical Device Manufacturing

FDA-Compliant Manufacturing Software

ISO 13485 and 21 CFR Part 11 compliant manufacturing system with DHF management, device history records, and complete traceability.

Medical Device Compliance

ISO 13485 Workflows
Quality management system built-in
Device History Records
Complete DHR from raw materials to finished device
21 CFR Part 11
Electronic signatures and audit trails

Live Medical Device Production Control Room

Real-time ISO 13485 and FDA 21 CFR Part 11 compliant operations with DHR automation, validation tracking, and complete traceability

Medical Device Production Control Room

ISO 13485 & FDA 21 CFR Part 11 Compliance

Live Data
FDA
100%
ISO 13485
100%
DHR
98.3%
CFR Part 11
100%
DHF Trace
100%
Validation
96.7%
Devices
284
Workers
11/15
Utilization
73%
Worker Stats - Day Shift
ISO 13485 Certified Personnel
Active Workers
11
of 15 total
ISO Certified
15
9 validation
Productivity
95.8%
E-Signatures
85
Today
DHR & Quality Control
Device History Records
DHF Documents
127
DHR Generated
284
CAPA Open
3
CAPA Closed
41
Complaints
2
Resolved
18
MDR Reports Filed
0
This quarter
Change Control
5
Open requests
Validation Support
IQ/OQ/PQ Protocols
IQ/OQ/PQ Complete
89
34 protocols active
Val. Reports
102
Total
Pending
4
In queue
Avg Val. Time
18.5d
Per protocol
Deviation Reports
6
This month
21 CFR Part 11
Electronic Signatures
Traceability Tests
75/75
E-Signatures
3247
Audit Trail
5841
Revision Control
412
Documents
Last FDA Inspection
47 days ago
0 483s
Surgical Instrument Assembly
MED-01 • 3 Workers • WO: WO-MD-24-3421
assembly
Device Number
DEV-SI-7842
Serial Number
SN-SI-2024-11247
Lot Number
LOT-2024-0847
Customer Order
CO-HOSPITAL-8821
Operation
Op 30 - Precision Assembly
ISO 13485 Stage
Production
Progress: 72.4%
Time in Station: 2h 25m
No Open CAPAs
Est. Completion: 65m
DHR & VALIDATION STATUS
DHR Status: in-progress
Validation: validated
E-Signatures: 12
DHF Linked: YES
DHF Mgmt
Linked
DHR
in-progress
Validation
validated
E-Sigs
12
CAPA
None
Complaint
Tracked
Implantable Device Clean Room
MED-02 • 2 Workers • WO: WO-MD-24-3422
inspection
Device Number
DEV-IM-4129
Serial Number
SN-IM-2024-08612
Lot Number
LOT-2024-0848
Customer Order
CO-CLINIC-5502
Operation
Op 60 - Sterility Testing
ISO 13485 Stage
Quality Hold
Progress: 88.7%
Time in Station: 3h 30m
1 CAPA Open
Est. Completion: 45m
DHR & VALIDATION STATUS
DHR Status: in-progress
Validation: validated
E-Signatures: 18
DHF Linked: YES
DHF Mgmt
Linked
DHR
in-progress
Validation
validated
E-Sigs
18
CAPA
1 Open
Complaint
Tracked
Diagnostic Equipment Station
MED-03 • 4 Workers • WO: WO-MD-24-3423
validation
Device Number
DEV-DX-9304
Serial Number
SN-DX-2024-05489
Lot Number
LOT-2024-0849
Customer Order
CO-LAB-3317
Operation
Op 80 - IQ/OQ/PQ Validation
ISO 13485 Stage
Verification
Progress: 91.2%
Time in Station: 3h 0m
No Open CAPAs
Est. Completion: 30m
DHR & VALIDATION STATUS
DHR Status: complete
Validation: pending
E-Signatures: 24
DHF Linked: YES
DHF Mgmt
Linked
DHR
complete
Validation
pending
E-Sigs
24
CAPA
None
Complaint
Tracked
Orthopedic Device Packaging
MED-04 • 2 Workers • WO: WO-MD-24-3424
packaging
Device Number
DEV-OR-2156
Serial Number
SN-OR-2024-09841
Lot Number
LOT-2024-0850
Customer Order
CO-SURGERY-7729
Operation
Op 100 - Final Packaging & Labeling
ISO 13485 Stage
Final Release
Progress: 96.8%
Time in Station: 0h 45m
No Open CAPAs
Est. Completion: 15m
DHR & VALIDATION STATUS
DHR Status: complete
Validation: validated
E-Signatures: 31
DHF Linked: YES
DHF Mgmt
Linked
DHR
complete
Validation
validated
E-Sigs
31
CAPA
None
Complaint
Tracked
Cardiovascular Device Line
MED-05 • 0 Workers • WO: Awaiting WO
idle
Device Number
n/a
Serial Number
n/a
Lot Number
n/a
Customer Order
n/a
Operation
Idle - Setup
ISO 13485 Stage
Standby
STATION IDLE - AWAITING WORK ORDER ASSIGNMENT
Ready for next medical device
Simulated live data - Updates every 2 seconds

Medical Device-Specific Features

DHF Management

Design History File tracking with revision control. Link design documents to production records. Complete traceability.

Device History Records

Automated DHR generation for every device. Serial and lot traceability. Material certification links.

Validation Support

IQ/OQ/PQ documentation. Change control workflows. Validation protocols and reports built-in.

Electronic Signatures

21 CFR Part 11 compliant e-signatures. Multi-level approval workflows. Complete audit trails.

CAPA Management

Corrective and preventive action tracking. Root cause analysis. Link CAPAs to production records.

Complaint Handling

Medical device complaint management. MDR reporting support. Investigation workflows and documentation.

Medical Device Success Story

Surgical Instruments Manufacturer
Class II medical device manufacturer, 85 employees

"MonitorZ transformed our FDA compliance. The DHR automation and electronic signatures saved us weeks during our last audit. The system is 21 CFR Part 11 compliant out of the box."

100%
FDA Audit Ready
70%
Faster DHR Creation
Zero
483 Observations

Ready for FDA-Compliant Manufacturing?

See how MonitorZ supports medical device manufacturers with ISO 13485 and 21 CFR Part 11 compliance.

Production ROI Calculator