QMS Software for Medical Device Companies
Manage document control, version history, electronic signatures, training records, CAPA, and quality processes in one ISO 13485-ready QMS built for MedTech teams.
John Smith
Start with the QMS work your team handles every day
qmsWrapper helps MedTech teams control documents, approvals, training, and CAPA records in one ISO 13485-ready system.
Document Control
Manage SOPs, policies, forms, revisions, approvals, and controlled document history.
Electronic Signatures
Review, approve, and release quality records with traceable electronic signatures.
Training Records
Track employee training, document read-and-understand tasks, and audit-ready evidence.
CAPA Management
Manage corrective actions, root-cause investigations, due dates, and effectiveness checks.
From Spreadsheets and Shared Folders to One Connected QMS
Document Control with Version History and Approvals
Manage SOPs, forms, work instructions, approvals, and revision history in one controlled system.
Connected CAPA, Risk, Training, and Documents
Related records stay connected automatically, reducing manual cross-checking before audits.
Always Audit Ready
Access approved documents, training records, signatures, and traceability at any time.
Most QMS Systems Manage Records. qmsWrapper Connects Them.
Many QMS tools can store documents, CAPAs, risks, and training records. The real challenge is keeping those records connected when one change affects the wider quality system.
Many platforms organize quality work into separate modules. qmsWrapper keeps related records connected across documents, CAPA, risk, requirements, training, and change.
Typical QMS Approach
- Documents are stored
- CAPAs are managed separately
- Risks are reviewed in another area
- Requirements and tests sit apart
- Relationships are checked manually before audits
qmsWrapper Approach
- Documents, CAPA, risk, and change stay connected
- Requirements link to risks, tests, and design records
- Training and approvals remain visible
- Change impact is easier to understand
- Audit evidence stays connected from daily work
Go Live in Weeks
Up and Running in Weeks
Most MedTech teams start managing documents, approvals, CAPA, and training records within weeks.
- No long implementation projects
- No complex customization
- No enterprise consulting cycles
Keep CAPA, Risk, Requirements, and Documents Connected
qmsWrapper connects quality records across document control, CAPA, risk management, design controls, training, and change management.
Instead of maintaining information in multiple spreadsheets and disconnected systems, your team works from one source of truth.
Start with Document Control. Expand as Your QMS Grows.
qmsWrapper supports startups, scale-ups, SaMD teams, and established medical device companies operating under ISO 13485, FDA QMSR, MDR, and IVDR requirements.
Start Simple
- Document Control
- Electronic Signatures
- Training Records
- Approval Workflows
Scale When Needed
- CAPA Management
- Risk Management
- Supplier Management
- Change Control
Support Growth
- Design Control
- Traceability Matrix
- Audit Management
- Post-Market Processes
What You’ll See During the Demo
A practical walkthrough of the QMS workflows MedTech teams use every day.
- Document Control and Version Management
- Electronic Signature Workflows
- CAPA and Root Cause Investigations
- Training and Competency Records
- Design Control and Traceability
- Risk Management and Change Control
- Audit Preparation Workflows
Schedule Your Personalized qmsWrapper Demo
See how a Medical Device QMS works in real regulatory scenarios.
Why MedTech Teams Chose qmsWrapper
“Being a small start-up company, having ISO 13485 to maintain and CE and FDA pending, we are quite happy how we use this software. The custom forms help us to completely transfer our work there instead of having to go back and forth between Word and software.”
“As a startup we were looking for a solution that's cost-effective to implement, with the functionality we need now, but that can scale up as our needs become more complex. qmsWrapper can grow with us.”
