FDA & ISO 13485 QMS Software for MedTech Teams

Built for growing medical device teams in 25+ countries, this FDA & ISO 13485 QMS software helps you manage CAPA, risk, and DHF in one audit-ready system.

24/7 Cloud access with AI-assisted workflows for global teams.

Pre-configured for FDA, ISO 13485, and MDR workflows.
Most teams go live in weeks, not months.

Book a 30-Minute QMS Demo

Watch 2-Min Overview

See how FDA & ISO 13485 QMS software connects QMS, DHF, risk, and change control in one audit-ready workflow.

Built for MedTech SMEs

Full traceability across QMS and DHF

No add-ons. One license

Why MedTech Teams Switch to qmsWrapper

Connected traceability
Link requirements, risk, CAPA, tests and changes automatically.

Built for MedTech SMEs
Structured workflows without enterprise complexity.

Fast implementation
Pre-configured system ready for regulated environments.

technical file traceability chaos vs structured AI QMS workflow

Trusted by MedTech teams in 25+ countries

qmsWrapper supports growing medical device and SaMD teams that need audit-ready quality processes without enterprise complexity.

Why Many QMS Approaches Break as Teams Grow

	Paper-Based / Manual QMS	Traditional QMS Software	qmsWrapper
Traceability	Manual and hard to maintain	Partly structured, often fragmented	Connected across QMS, DHF, risk, and change
Change impact	Manual analysis across multiple documents	Often requires manual cross-checking between modules	Related records stay visible across requirements, risk, and design data
Audit prep	Time-consuming	Better, but still document-heavy	Live audit-ready records
CAPA, risk, DHF	Separate files and folders	Often handled in separate modules	Structured and connected in one system
Team visibility	Limited	Partial	Shared real-time visibility
Daily work	Admin-heavy	Process exists, but can feel rigid	Guided workflows with AI-assisted support

What works in the early stage often breaks when one issue touches CAPA, risk, validation, design, and documentation at the same time.

Modern, clean team workspace in the foreground with four professionals collaborating around a white desk, while a large, blurred corporate office environment fades into the background, symbolizing complexity versus clarity. ISO 13485 QMS software

Implementation

Most MedTech teams start using qmsWrapper within weeks.

This FDA & ISO 13485 QMS software is pre-configured for regulated workflows, so your team can begin structuring CAPA, risk, design control, and documentation without long configuration projects.

No complex customization.
No enterprise implementation cycles.

One Connected System for QMS, DHF, Risk, and Change

qmsWrapper gives MedTech teams one structured system where deviations, CAPAs, risks, requirements, tests, approvals, and documents stay linked automatically.

Instead of rebuilding the story before every audit, your team works in a live system of record from the start.

AI-assisted workflows help reduce manual data entry by pre-filling forms, transferring linked information between records, and suggesting relevant related items while keeping all decisions fully human.

Design to post-market QMS lifecycle architecture showing connected DHF, risk management, CAPA, verification, and ISO 13485 & FDA compliance flow

FDA & ISO 13485 QMS software dashboard: qmsWrapper software showing a structured change approval process workflow in a medical device QMS

Complete FDA ISO 13485 QMS Software for MedTech SMEs

Event-Driven QMS for deviations, nonconformances, complaints, and change
CAPA and root-cause workflows
Design Control and Traceability Matrix
ISO 14971 Risk Management
Document Control and 21 CFR Part 11 eSignatures
Audit and Supplier Management
Training and Competence Records
AI-assisted Smart Forms

No add-ons. No hidden modules. One connected system.

Built for MedTech SMEs — Not Enterprise Bureaucracy

qmsWrapper is designed for teams that need structure, speed, and traceability without long implementation projects or complex customization.

Up and running in weeks
Pre-configured for regulated workflows
Easier adoption across quality, regulatory, and engineering teams
Clear visibility from event to action to closure

ISO 13485 & FDA compliance structured within a connected QMS architecture linking design controls, risk management, CAPA, and document control

Pre-Validated and Ready for Regulated Environments

qmsWrapper supports teams working under:

FDA 21 CFR Part 820
FDA 21 CFR Part 11
ISO 13485
ISO 14971
EU MDR and IVDR
UK MDR
SaMD and regulated software environments

With a single system of record, every change, deviation, and CAPA
stays connected and audit-ready.

What You’ll See in the Live Demo

During the live demo, we’ll show you:

how CAPA, change, and risk stay connected
how traceability links requirements, tests, and DHF records
how AI-assisted forms reduce manual work
how qmsWrapper supports faster audit preparation
how quickly your team can get started

No generic sales pitch. Just a practical walkthrough of workflows MedTech teams use every day.

See how qmsWrapper connects CAPA, risk, and DHF in real workflows.

Request a personalized demo using the form.

Or, if it’s easier, book a time directly.

Schedule Your Personalized qmsWrapper Demo

See how a Medical Device QMS works in real regulatory scenarios.

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Testimonials

What our clients said

“Being a small start-up company, having ISO 134185 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.”

Alex Hayes
(CTO, Inova Medical)

“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.”