ISO 13485 Quality Management Software

Connect medical-device quality from design through post-market activity

Zebsoft brings your ISO 13485 requirements, design controls, suppliers, equipment, quality workflows, complaints, nonconformities and corrective actions into one connected assurance environment.

ZAP works alongside your existing ERP, MRP, MES and specialist systems—governing the quality decisions, evidence and exceptions surrounding the medical-device lifecycle.

Govern design

Control reviews, approvals, verification, validation and design changes.

Assure manufacture

Connect equipment, suppliers, specifications and quality evidence with production references.

Close the loop

Turn complaints, defects and audit findings into investigated and verified improvement.

The assurance gap

Your manufacturing system records what happened. Who assures what should happen next?

Medical-device quality evidence is often divided between controlled documents, spreadsheets, supplier records, manufacturing systems, calibration certificates, complaints and separate action trackers.

Each system may perform its own function, but quality decisions become harder to connect.

Operational workflow illustrating Supplier Management Software managing the complete supplier lifecycle from supplier onboarding and validation through approval, ongoing compliance monitoring, supplier audits and continuous improvement. Connected workflow demonstrates traceability, operational control and supplier assurance within the Zebsoft Assurance Platform.

A production deviation may affect a batch, supplier, approved specification, risk control or released product. A complaint may reveal a recurring defect. An equipment failure may call previous inspection results into question.

Zebsoft creates the connected assurance record around these events so that their wider quality impact can be understood, assigned and resolved.

Disconnected evidence

Quality records exist, but their relationships are difficult to demonstrate.

Delayed escalation

Failures are recorded without consistently triggering the right review or response.

Uncertain impact

Changes and deviations are not always assessed against products, risks, equipment and suppliers.

Incomplete closure

Actions may be completed without confirming that they were effective.

One connected quality environment

Bring the parts of your ISO 13485 system together

Zebsoft provides a configurable ISO 13485 compliance domain supported by the operational capabilities of V2 and the dynamic assurance provided by ZAP.

The compliance domain defines the requirements, processes, responsibilities and controlled information. V2 manages the workflows and records used to operate the system. ZAP checks whether controls remain complete, current and supported by evidence.

Define
Establish requirements, responsibilities, processes, risks and expected evidence.

Govern
Use controlled workflows, forms, approvals and decision gates.

Operate
Complete reviews, inspections, evaluations and quality activities.

Assure
Identify missing evidence, overdue controls, recurring failures and unresolved exceptions.

Improve
Connect findings with change, risk, CAPA and management review.

Controlled product development

Govern design decisions without turning your QMS into a product-development system

Configurable ZAP workflow forms can govern the quality stages surrounding medical-device design and development.

Workflows can be configured to control:

  • Design and development planning
  • Design inputs and outputs
  • Formal design reviews
  • Verification and validation
  • Design transfer
  • Manufacturing-readiness reviews
  • Design changes
  • Required approvals and evidence

Each workflow can identify what must be reviewed, who is responsible, what evidence is required and whether the stage is ready to progress.

ZAP can challenge incomplete approvals, missing verification evidence, unresolved risks and changes that have not been reflected in documents, training or downstream controls.

Zebsoft governs the design-control process and its evidence. It does not attempt to replace specialist engineering, CAD or product lifecycle management systems.

Assurance around production

Connect quality governance with the systems operating manufacture

Your ERP, MRP or MES remains responsible for production planning, materials, stock, work orders and manufacturing transactions. Zebsoft provides the connected assurance layer around those activities.

Client-managed data sources allow ZAP workflows to reference operational information such as:

  • Product, device and model
  • Batch, lot and serial number
  • Production or work order
  • Component and material code
  • Supplier and manufacturing location

This information can support manufacturing-readiness reviews, inspections, release decisions, deviations, concessions, nonconforming product and manufacturing changes—without duplicating the complete production history inside Zebsoft.

Manufacturing system

  • Operates production and manufacturing transactions
  • Manages materials, stock and work orders
  • Remains the manufacturing system of record

Zebsoft and ZAP

  • References the relevant production identifiers
  • Governs quality reviews, approvals and evidence
  • Manages deviations, exceptions and corrective action
  • Assures that required controls have been applied
  • Provides the connected assurance record

Zebsofts open API and Zapier connectivity will provide additional integration routes, allowing approved operational data and events to initiate, update or receive outcomes from ZAP workflows.

Manufacturing systems operate production. Zebsoft governs and assures the quality controls surrounding it.

Apply ISO 13485 controls to the equipment that can affect product quality

Zebsoft equipment records respond to the standards selected by the customer. When ISO 13485 applies, the record can expose the fields and controls needed for production, inspection, testing and measurement equipment.

Applicable information can include:

  • Intended use and responsible owner
  • Product-quality impact and criticality
  • Qualification and operational status
  • Calibration requirements and tolerances
  • Maintenance, servicing and inspection
  • Last and next scheduled activity
  • Certificates and supporting evidence
  • Applicable procedures and instructions
  • User competence requirements
  • Software or firmware version
  • Out-of-tolerance results
  • Related deviations, risks and CAPA
  • Decommissioning and disposal evidence

The Activity Schedule manages recurring work. ZAP monitors completion, evidence and exceptions.

If equipment is overdue, fails calibration or is found outside tolerance, the assurance process can consider whether previous inspections, measurements or released products may be affected.

Suppliers and outsourced processes

Maintain assurance beyond your own organisation

Medical-device quality depends on suppliers, external manufacturers and outsourced processes remaining capable, approved and properly controlled.

Zebsoft connects supplier approval, evaluation, evidence and performance within the wider ISO 13485 system.

Use it to govern:

  • Supplier selection and initial approval
  • Risk-based supplier classification
  • Due diligence and qualification evidence
  • Certificates and expiry dates
  • Quality and technical agreements
  • Supplier audits and assessments
  • Performance reviews and scorecards
  • Supplied-product defects
  • Corrective action and escalation
  • Reapproval, suspension or removal

The Supplier Portal allows approved external users to provide information, complete assigned activities and respond to findings without entering the internal quality environment.

ZAP can identify expiring evidence, overdue evaluations, recurring defects and suppliers whose current performance no longer supports their approval status.

Suppliers and outsourced processes

Keep product risks connected with current evidence

ISO 13485 quality controls and ISO 14971 product-risk activities should not become isolated records.

Risk 360° can provide a configurable structure for recording product risks and linking them with the processes, suppliers, equipment, controls and evidence used to manage them.

Zebsoft can support the governance of relationships such as:

ZAP can then challenge whether:

  • Required risk controls remain implemented
  • Verification evidence is current and approved
  • A complaint or defect indicates a changed risk
  • A design or manufacturing change introduces a new hazard
  • Supplier or equipment failures affect an existing control
  • Residual risk requires further review or approval

Hazard → Hazardous situation → Harm → Risk control → Verification evidence → Residual risk

Zebsoft supports the governance and assurance of risk activity. The precise configuration can be aligned with the organisation’s established ISO 14971 methodology.

Quality after release

Bring post-market signals back into the quality system

Complaints, product defects, audit findings, supplier failures and process deviations should not remain separate events.

Configurable ZAP workflows can guide each event through the appropriate quality response:

  • Product and batch references
  • Existing risks and controls
  • Similar complaints or defects
  • Supplier performance
  • Investigation and CAPA
  • Change management
  • Audit activity
  • Management review

The same connected record can reference the affected product, batch, supplier, equipment, process or work order.

ZAP provides oversight of overdue containment, incomplete investigations, repeated failure and CAPA closed without sufficient effectiveness evidence.

Quality after release

Bring post-market signals back into the quality system

Released products continue to generate information through complaints, returns, service activity, adverse-event assessments, supplier feedback and performance trends.

Zebsoft can govern the workflows used to assess these signals and connect them with:

  • Record the event and affected reference
  • Assess severity and immediate impact
  • Apply containment or correction
  • Investigate the cause
  • Determine whether CAPA is required
  • Assign and complete actions
  • Review effectiveness
  • Update risks, processes or controls
  • Monitor for recurrence

 

Configurable workflows can support reportability and escalation decisions while retaining the evidence, responsibility and approval history behind them.

Regulatory submissions remain the responsibility of the manufacturer and its appointed regulatory specialists. Zebsoft provides the controlled assurance record supporting the decision and subsequent action.

From records to assurance

ZAP does more than show that a record exists

A static QMS can show that a procedure, approval or action has been recorded. ZAP examines whether the control remains credible in the light of current evidence.

ZAP assurance cycle

Detect
Identify missing evidence, overdue controls, changed data and emerging patterns.

Analyse
Consider relationships across products, risks, suppliers, equipment and quality events.

Recommend
Present the appropriate review, escalation or corrective response.

Evidence
Retain the information, approval and reasoning supporting the decision.

ZAP at the centre of a six-stage dynamic assurance cycle connecting detection, analysis, evidence, resolution and improvement.

Resolve

Assign responsibility and follow the issue through to controlled closure.

Improve
Feed the outcome back into risks, processes, documents, training and management review.

From ISO 9001 QMS to Enterprise Quality Management

The right quality system depends on what the organisation needs to control.

Building or Maintaining ISO 9001

If certification is the primary requirement, Zebsoft can provide the structure and evidence needed to support ISO 9001, including documented information, risks and opportunities, objectives, audits, corrective action and management review.

Managing Quality Complex Enterprise

Organisations operating across multiple sites, departments, suppliers or regulated activities may require broader enterprise quality management, reporting and oversight.

Zebsoft allows the quality system to develop without replacing the platform or separating the organisation’s quality information.

ISO 13485 QMS capabilities

Configure Zebsoft around the way your medical-device QMS operates

Quality area Zebsoft capability
Documented information Approval, issue, version, review, acknowledgement and retention controls.
Design governance Configurable workflows, reviews, approvals, verification and validation evidence.
Product risk Connected risks, controls, evidence, change and quality-event relationships.
Supplier control Approval, evaluation, portal, audit, evidence and performance monitoring.
Equipment Standard-responsive records, calibration, maintenance and activity scheduling.
Production assurance Inspection, release, deviation and manufacturing-change workflows.
Traceability Product, batch, lot, serial and work-order references within assurance records.
Complaints Controlled assessment, investigation, escalation and trend review.
Nonconformity Containment, disposition, investigation and related action.
CAPA Root cause, action, responsibility, effectiveness and recurrence monitoring.
Audit Programmes, checklists, findings, actions and assurance relationships.
Competence Process- and equipment-related training needs and supporting records.
Change control Impact assessment across risks, documents, training, equipment and suppliers.
Management review Objectives, KPIs, trends, exceptions and unresolved quality concerns.
Integration Client-managed data sources, API connectivity and supported integrations.

From records to assurance

Move from disconnected quality records to connected assurance

Zebsoft can be configured around the organisation’s existing ISO 13485 system rather than forcing every customer into an identical model.

Implementation can include:

  • Defining the ISO 13485 compliance domain
  • Mapping processes, responsibilities and requirements
  • Configuring ZAP workflow forms and approvals
  • Importing controlled documents and existing registers
  • Establishing supplier and equipment records
  • Creating client-managed operational data sources
  • Connecting risks, complaints, nonconformities and CAPA
  • Preparing API or Zapier integrations where required
  • Training system owners and operational users

Existing ERP, MRP, MES, engineering and regulatory systems can remain in place. Zebsoft connects the assurance activity surrounding them.

Connected medical-device quality

An assurance platform—not another isolated QMS database

Zebsoft helps medical-device organisations define their quality controls, govern the workflows that apply them and assure that the expected evidence remains complete.

It connects design decisions, product risks, suppliers, equipment, manufacturing references, complaints and CAPA without attempting to replace the specialist systems that operate engineering or production.

The result is a clearer view of whether the medical-device quality system is working—not simply whether its records exist.

Frequently Asked Questions About QMS Software

ISO 13485 software helps medical-device organisations control and evidence the processes used within their quality management system. Depending on its scope, it can support documented information, supplier controls, design governance, equipment, complaints, nonconformities, CAPA, audits and management review.

Zebsoft combines these QMS capabilities with ZAP dynamic assurance, helping organisations identify incomplete controls, missing evidence and unresolved quality exceptions.

No software can guarantee ISO 13485 certification. Certification depends on the organisation establishing, operating and maintaining an effective quality management system that meets its applicable requirements.

Zebsoft provides the structure, workflows, records and assurance tools used to support that system and demonstrate how it is being controlled.

No. Your ERP, MRP or MES remains responsible for production planning, materials, stock, work orders and manufacturing transactions.

Zebsoft governs the related quality workflows, approvals, evidence, deviations, investigations and corrective actions.

Yes. Client-managed data sources can provide product, batch, lot, serial and work-order references for use within ZAP workflow forms and quality records.

V2’s open API and Zapier connectivity will provide further options for exchanging approved data with operational systems.

Zebsoft can use configurable ZAP workflow forms to govern design inputs, outputs, reviews, verification, validation, transfer and design changes.

It provides design-control governance and evidence management rather than replacing specialist engineering or product lifecycle management software.

Risk 360° can be configured to support product-risk relationships and connect risk controls with verification evidence, complaints, changes, suppliers and equipment.

The configuration should reflect the organisation’s established ISO 14971 methodology and regulatory responsibilities.

V2 equipment records respond to the standards selected by the customer. ISO 13485 configurations can include qualification, calibration, maintenance, tolerances, product-quality impact and out-of-tolerance controls.

Recurring work is managed through the Activity Schedule, while ZAP monitors evidence, status and exceptions.

Yes. The Supplier Portal can allow approved external users to provide information, complete assigned activities, upload evidence and respond to findings without giving them access to the internal quality environment.

Yes. Configurable workflows can guide complaints, defects and nonconformities through assessment, containment, investigation, root cause, corrective action and effectiveness review.

ZAP can identify overdue responses, repeated failure and CAPA that lacks adequate evidence of effectiveness.

Yes. Existing controlled documents, registers and structured data can be reviewed and mapped into the appropriate Zebsoft records.

Implementation can retain links with existing operational systems while progressively replacing disconnected spreadsheets and action trackers.

Discuss your ISO 13485 quality system with Zebsoft

See how Zebsoft can connect your design controls, suppliers, equipment, manufacturing references, complaints, product risks and CAPA within one configurable assurance environment.

We will focus the demonstration on your existing systems, quality processes and the areas where stronger connection or oversight would provide the greatest value.