The legacy approach
Paper DHRs & Manual Records
Incomplete or illegible records surface as findings during FDA inspection.
The VKS advantage
Automatic eDHR
A complete, legible device history builds itself as each unit is assembled.
Connected worker platform for
Medical Devices Manufacturing
Enforce regulatory compliance at every phase of production. VKS provides visual operator guidance, enforced e-signature checkpoints, and automatic inspection-ready eDHRs.
Certifications:ISO 13485FDA 21 CFR Part 82021 CFR Part 11UDIISO 14971
Certifications:
ISO 13485FDA 21 CFR Part 82021 CFR Part 11UDIISO 14971
The Zero-Tolerance Reality of Medical Devices
When device history lives on paper and process control depends on operator memory, you're exposed to incomplete DHRs, failed FDA inspections, and recalls you can't scope.
The legacy approach
The operational risk
The VKS advantage
Paper DHRs & Manual Records
Incomplete or illegible records surface as findings during FDA inspection.
Automatic eDHR
A complete, legible device history builds itself as each unit is assembled.
Signatures Collected After the Fact
Unattested steps and missing sign-offs break Part 11 compliance.
Enforced E-Signatures
Required attestations captured at the step, in real time.
Process Control By Operator Memory
Skipped or out-of-sequence steps affect finished devices.
Validated Process Control
Enforced visual steps require verified checks and signatures before advancing.
The legacy approach
Signatures Collected After the Fact
Unattested steps and missing sign-offs break Part 11 compliance.
The VKS advantage
Enforced E-Signatures
Required attestations captured at the step, in real time.
The legacy approach
Process Control By Operator Memory
Skipped or out-of-sequence steps affect finished devices.
The VKS advantage
Validated Process Control
Enforced visual steps require verified checks and signatures before advancing.
What VKS Does for Medical Device
Deploy VKS as a standalone system to enforce regulatory compliance, or connect it directly with your ERP, PLM, and BI platforms to maintain audit readiness enterprise-wide.
Automatic eDHR
Electronic Device History Record is automatically established, as each unit is built.
Visual Work Instructions
Standardize complex processes with step-by-step guidance to ensure flawless execution.
Validated Process Control
Quality checkpoints prevent operators from advancing until every quality check passes.
Enforced E-Signatures
Part 11 attestations captured at the step, in real time.
Audit Trail & System Compliance
Comprehensive audit logs track every operator action, parameter change, and system event for complete FDA readiness.
How VKS is Tailored for Medical Device Workflows
1
Sub-Build Open
Scan the work order to launch guided assembly for sub-components or modular sub-assemblies.
2
Component & Lot Scan
Scan serial and lot barcodes for raw materials, sterile components, or sub-boards to build genealogy.
3
Sub-Unit Validation
Capture required torque values, measurements, or visual validations for the sub-assembly.
4
Parent Record Merge
Scan the completed sub-assembly at final assembly to automatically link its full history to the parent eDHR.
FAQs
Medical Devices
Compliance, deployment and integration questions we hear most from regulated shop floors.
Talk to our teamHow is VKS used in medical device manufacturing?
VKS is a work instruction software for zero-defect medical device assembly. Instead of relying on paper records or post-assembly sign-offs, VKS guides technicians through validated, step-by-step procedures. The platform enforces mandatory in-process inspection gates, prompts real-time e-signatures, and auto-compiles an inspection-ready electronic Device History Record (eDHR) for every serial number produced.
How does VKS support FDA 21 CFR Part 820 and ISO 13485 compliance?
Unlike rigid legacy MES platforms that require months of custom coding and expensive consultants to reconfigure validated workflows, VKS delivers an agile compliance layer into the process. Quality teams can build, test, and deploy validated visual procedures directly. The platform holds steps in sequence until required checks and Part 11 e-signatures pass, automatically compiling an immutable eDHR ready for instant retrieval.
Does VKS support 21 CFR Part 11 electronic signatures and audit trails?
Yes. VKS captures secure electronic signatures at the point of work, so an authorized user attests to critical steps in real time rather than signing a batch record afterward. Its audit log records system actions (the user, time, and location), giving administrators a traceable record of who did what and when. Combined with role-based access control, this supports the electronic-records and electronic-signature expectations of 21 CFR Part 11.
How does VKS prevent operators from using uncalibrated tools or equipment during assembly?
VKS Edge connects directly to shop floor smart tools, gauges, and test equipment, automatically verifying their calibration status prior to use. If a tool's calibration date has expired, VKS locks the workstation step and prevents the operator from proceeding until a calibrated tool is connected or verified. Every tool ID and calibration expiration date used during assembly is automatically logged into the unit's eDHR.
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