Medical Device QMS

A validated, configurable, automated and integrated QMS.

For whether you’re on day 1 or at the postmarket stage.


Save time, effort and errors with a complete suit of automated and integrated solutions.

Paper-based processes are a nightmare from start to finish. From trying to get approval from a handful of stakeholders to finding documents among dozens of binders, manual processes are prone to errors and full of obstacles.


Manage your quality events in an automated and integrated system.


Your manufacturing activity documentation integrated with quality events.


Create electronic forms easily manage and integrate clinical trial data with your design processes.


Manage your regulatory affairs and submissions.


Easily manage quality processes and documentation with your suppliers.


Manage your design documents and easily draw conclusions from your quality events in real time.


Manage complaints and adverse events.

Easily store distribute and access information in real time!

Take a quick look at the SAMURAI Medical Device QMS platform

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What can SAMURAI do for you?


Inefficient document control is the greatest detriment to compliance, dealing with time-consuming, redundant tasks; trying to keep track of documents and document versions; and never knowing who’s trained on what.

Affordable document control software goes a long way in easing that burden and making success possible.

Introduce automation into your processes. A digital document control solution is not only more efficient, it also makes it easier to keep up on regulatory changes, maintain compliance while reducing costs and accelerates time to market.

Transferring to a digital system isn’t just great for your document control — it also benefits any related processes. As part of a quality management system (QMS), document control simplifies training, corrective and preventive action (CAPA), supplier management, audits and more. The same interconnectivity that improves document control also streamlines the interaction between different aspects of a QMS.

Complying with regulations and standards is more efficient with digital solutions. Manual or hybrid systems are error-prone, cause delays and introduce product quality problems that can result in harsh regulatory penalties.

Digital document management systems allow you to truly manage your documents, thereby maintaining compliance and increasing profitability.

Making sure staff stays up to date with quality process training takes a lot of effort, but it’s essential for compliance. The employee training management system takes care of all training administration tasks. This gives training coordinators more time to focus on creating effective programs that keep employees qualified for their roles.

Communicating a change across the entire organization without anything falling through the cracks is nearly impossible, yet effortless with an automated system.

Change is rarely isolated. A change in one area will affect others. On paper-based or manual processes, those areas aren’t connected. This leads to miscommunication and delays. A quality management system (QMS) that is connected to other systems ensures compliance beyond the quality department.

An automated system ensures everyone knows about a change. Document routing, tracking and approval all happen automatically. When a change is needed for compliance, a system that minimizes human error by automation is essential.

A change isn’t compliant if you can’t show it happened. A digitized system will track changes that have been made and archive older versions. This puts your organization into an audit-ready state and ensures you can maintain that state. 

Employees need to be aware of and trained on an engineering or document change. When your quality processes are all on the same platform, any change will automatically send out training to employees.

To be compliant, manufacturers need reliable engineering change management (ECM). An unavailable part, safety concern or new regulation all mandate an engineering change. To stay compliant, avoid recalls and save on costs, companies need cloud-based, automated change management.

Get the confidence that gaps in employee training don’t derail your regulatory compliance. 

Automate all training tasks, from routing and tracking to follow-up and escalation. Your compliance will never be at risk due to lack of employee training.

Employees need to be informed of training requirements. Then, they report when their training is complete. Manual tracking, follow-up and escalation processes are slow and prone to error. Training scheduling software resolves these issues by automating all training coordination tasks.

Process changes often require document updates and new training. Connecting documentation and training processes keeps employees’ procedure training up to date. This prevents the risk of staff performing their jobs based on outdated SOPs, manuals and other documents. Your training data and documents are stored and easily retrieved from one place. You are always ready for audits and inspections.

Improving quality and maintaining compliance depends upon robust CAPA management. A digital and integrated CAPA solution allows companies to connect key quality channels and downstream processes throughout the entire product life cycle. The result is streamlined and thorough CAPA management for better product quality, safety and overall compliance.

Automate CAPA processes such as routing, notification, escalation and approvals to avoid bottlenecks and expedite issue resolution.

A fully digitized and automated CAPA system provides the ability to launch forms directly from customer complaints, deviations, nonconformances, audits, out of specifications and more.

With visibility into the entire CAPA process, you can analyze data and identify trends to help improve overall quality management.

When CAPA is integrated with core quality management systems, automatic initiation of change control, training verification and task tracking ensure compliance with FDA 21 CFR Part 11 requirements.

A nonconformance can lead to rework, scrap or – even worse – a product recall. Introduce automation and integration with related processes to identify, evaluate, review and manage nonconformances efficiently.

Streamline and automate the processes of documenting, investigating, and resolving product deviations in real time.

Interconnected OOS investigation and documentation of the results. software lets you comply with U.S. Food and Drug Administration (FDA) regulations and ISO standards. Current good manufacturing practices (CGMPs) require regulated manufacturers to follow specifications that define parameters for a product. When a product is OOS, a company must.

Sometimes an OOS is a sign of a bigger problem. If a corrective action preventive action (CAPA) is required, a CAPA form can be started directly from the OOS product. This reduces human error and ensures continuity.


Document Control
Change Control
Training Management
CAPA Software
Deviations Management
Out of Specification
Audit Management
Quality Management
Risk Management
Data and Analytics


Design Control
Change Control Software
Change Management Software
Change Order
Change Management Tool


Clinical Management
Trial Master File
Trial Software
TMF Checklist


Device History Records
Equipment Calibration
Recipe Management System
Variant Management


Supplier Management
Bill of Materials
Supplier Management Audits
Vendor Management
Supplier Scorecard
Supplier Corrective Action Request
Supplier Deviation


Regulatory Information Management (RIM)
Submissions for 510(K) and PMA
Submissions for eCTD
Submissions Management
510K Guidance
CTD File


Customer Complaints
Medical Device Reporting (eMDR)
Complaint Tracking System
Complaint Example
Device Reporting Software

Accelerate compliance with a complete quality automation

Get an interactive demo of all the SAMURAI features and abilities. We are here to assist and guide you throughout the process.

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