Regulatory Documents
Medical Device Design & Development QMS
Hybrid system aligned with FDA 21 CFR 820 and ISO 13485:2016, focused exclusively on medical device programs.
One-Page QMS Summary
A client-facing overview of how Zewski Corporation manages quality, documentation, and compliance through medical device development.
QMS Scope
Zewski Corporation’s Quality Management System governs all activities related to design and development of medical devices, including mechanical, electromechanical, feasibility, prototyping, DFM, verification planning, and design transfer.
Regulatory Alignment
- FDA 21 CFR Part 820 – Quality System Regulation
- ISO 13485:2016 – Medical Device QMS
- Risk management activities aligned with ISO 14971
Core Controlled Processes
- Design & Development (inputs, outputs, reviews, traceability)
- Risk Management Files & Risk Controls
- Document & Change Control (DCR/ECR)
- Supplier Management
- Inspection & Test Documentation
- Training & Competency
- Internal Audits
- CAPA & Management Review
Standard Outputs to Clients
- DHF components (design files, test data, plans, minutes)
- DMR elements (drawings, BOM, specifications)
- Risk files and traceability sheets
- Verification protocols and reports
Full QMS Outline
A detailed overview of how our QMS governs your medical device development program.
QMS Structure
- Quality Manual: Defines scope, exclusions, and process interactions.
- Standard Operating Procedures (SOPs): Core governance over design, risk, change control, suppliers, testing, and audits.
- Templates & Forms: Plans, logs, protocols, reports, and meeting minutes.
- Master Document List: Central ledger of all controlled documents.
- DHF / DMR Structure: Organized design history and manufacturing documentation.
- Training Records: Demonstrates competency for QMS-relevant activities.
Design & Development Controls
- Formal design plans and gated progress tracking.
- Documented design inputs with traceability.
- Structured design reviews and action logs.
- Integration of risk management at each stage.
- Test planning (verification and validation).
Risk Management
- Risk Management Plans per project.
- Hazard identification, analysis, and mitigations.
- Residual risk evaluations.
- Traceability between risks, controls, and tests.
Document, Change & Record Control
- Numbered, controlled documents with revision management.
- Document Change Request (DCR) and Engineering Change Request (ECR) processes.
- Secure design records with retention rules.
- Version control for templates, forms, and SOPs.
Supporting QMS Processes
- Supplier qualification and ongoing monitoring.
- Internal audits & quality improvement.
- Corrective and Preventive Action (CAPA).
- Management Review oversight.
QMS Process Flow
A high-level view of your device’s path through Zewski’s controlled quality system.
User Needs
➝
Design Planning
➝
Design Inputs
➝
Risk Analysis
➝
Design Outputs
➝
Verification & Validation
➝
Design Transfer
Capability Statement
How our QMS and engineering infrastructure support your device’s regulatory path.
Core Competencies
Medical Device Development
- Mechanical & electromechanical systems.
- Proof-of-concept through DFM.
- Prototype builds and testing.
- Traceability-integrated documentation.
Regulatory Alignment
Compliance Execution
- 21 CFR 820.30 & ISO 13485 compliant design controls.
- DHF, DMR, risk files, test documentation.
- 510(k), De Novo, and Class I support.
Differentiators
Experience & Infrastructure
- 30 years industry experience.
- 20+ patented medical devices.
- In-house prototyping & testing.
- Collaborative client workflow.
Design Control Workflow
How design, risk, testing, and documentation move through our QMS.
User Needs
➝
Design Inputs
➝
Risk Analysis
➝
Design Outputs
➝
Verification
➝
Validation
➝
Design Transfer
Design Control Artifacts
- Design Plan
- Design Inputs
- Risk Management Plan
- Risk Analysis
- Design Outputs
- Verification Plans
- Validation Plans
- Test Protocols
- Test Reports
- Design Review Minutes
- DHF Index
- DMR Components
SOP & Template Titles
Representative documents from the Zewski QMS.
Core SOPs
- SOP_Design & Development
- SOP_Risk Management
- SOP_Document Control
- SOP_Change Control
- SOP_Supplier Management
- SOP_Inspection & Acceptance
- SOP_Production & Assembly
- SOP_Training & Competency
- SOP_Internal Audits
- SOP_CAPA
- SOP_Management Review
- SOP_Calibration & Maintenance
Templates & Logs
- Template_BOM
- Template_DMR
- Template_Design Plan
- Template_Design Inputs
- Template_Action Items Tracker
- Template_Risk Analysis
- Template_RMP
- Template_Test Protocol
- Template_Test Report
- Template_Validation Plan
- Template_IOW Matrix
- Log_Training Record
- Log_Inspection Record
- Log_Internal Audits
- Log_NCRs
- Log_DCRs
- Form_DCR
- Form_ECR
- Form_Audit Checklist
- Form_CAPA
- Form_MR Minutes
Controlled Document List (Selected)
A representative subset of controlled documents used in our QMS.
| Document Number | Title | Category |
|---|---|---|
| 000-100-QA-00 | Quality Manual | Quality Manual |
| 000-100-DD-01 | SOP_Design & Development | SOP |
| 000-100-RM-01 | SOP_Risk Management | SOP |
| 000-100-DC-01 | SOP_Document Control | SOP |
| 000-100-CC-01 | SOP_Change Control | SOP |
| 000-100-SM-01 | SOP_Supplier Management | SOP |
| 000-100-IA-01 | SOP_Inspection & Acceptance | SOP |
| 000-100-PA-01 | SOP_Production & Assembly | SOP |
| 000-100-TR-01 | SOP_Training & Competency | SOP |
| 000-100-AU-01 | SOP_Internal Audit | SOP |
| 000-100-CA-01 | SOP_CAPA | SOP |
| 000-100-MR-01 | SOP_Management Review | SOP |
| 000-100-EM-01 | SOP_Calibration & Maintenance | SOP |
| 000-100-DD-02 | Template_DMR | Template |
| 000-100-DD-03 | Template_Design Inputs | Template |
| 000-100-DD-04 | Template_Action Items Tracker | Template |
| 000-100-RM-02 | Template_RMP | Template |
| 000-100-RM-03 | Template_Risk Analysis | Template |
| 000-100-DD-09 | Template_Test Protocol | Template |
| 000-100-EM-01 | Template_Test Report | Template |
| 000-100-DD-10 | Template_Validation Plan | Template |
| 000-100-DD-12 | Template_IOW Matrix | Template |
| 000-100-TR-02 | Log_Training Record | Log |
| 000-100-NC-01 | SOP_Nonconformance Control | SOP |
| 000-100-NC-02 | Form_Audit Checklist | Form |
| 000-100-NC-03 | Log_NCRs | Log |