Quality Management Software
for end-to-end ISO 13485 Compliance

Streamline your quality processes in pre-market or post-market, all under one roof - Easily, deploy, manage and optimize quality and compliance automation.
 
TRUSTED BY
 

Choose the right solution for your growth needs, from essential to Enterprise QMS and beyond.

Design Control
Management

Training
Management
Quality Events
Non-Conformance
Management
Supplier
Quality
Risk
Management
Document Control
Complaints
Management
CAPA
ECO
DHR
Equipment & 
Maintenance
Regulatory
Affairs
Audit
Management

All the tools you need to be compliant with ISO 13485

Designed for emerging medical device companies with built-in growth features:

Validation
Package

Analytics

Pre-Configured

Processes

Seamless Deployment

Ditch the heavy-lifting & deploy in days.

Learn more about how you can easily implement, deploy and optimize your QMS with Dot Compliance's ready-to-use solutions.

One source to streamline quality

Easily connect data, people, and processes with one quality ecosystem,

Drive Efficiency

Automate quality processes, easily collect e-signatures, send alerts and track your efforts in real time. The right automation, at the right time, for the right people. 

Reduce costs

Reducing TQM and production costs by leveraging the power of a quality platform that enables you to be proactive and act by signals, not noise.

Accelerate time to value

Go live with an all-in-one eQMS in a matter of weeks. Our 'out-of-the-box' platform comes with pre-engineered and pre-validated processes allow you to get on board and gain value faster. 

Create a quality culture

Access the right tools to make your organization truly quality-driven. Quickly drive engagement with employees and management anywhere, anytime, from any device.

Gain cross-organization
visibility

Unlock real-time visibility on end-to-end quality efforts. Create insightful dashboards and reports to see trends, insights and what actually matters.

COMPLIANT WITH

FDA 21
CFR PART 11
EU
ANNEX 11
ISO 9001
FDA 21 CFR
PART 820
GAMP 5
ISO 13485
ISO 27001
ISO 14971

Start streamlining quality
with Dot Compliance Quality Platform

A simple, powerful and affordable way to manage your quality processes.