Safe, Reliable, and Compliant
Azumuta for the Medical Devices Industry
In the medical devices industry, companies are responsible for designing and manufacturing products that meet rigorous safety and efficacy standards. The adoption of digital technologies is revolutionizing the sector through innovations enhance precision in manufacturing, improve quality control, and facilitate compliance with complex regulatory frameworks. Azumuta enables better production monitoring, an efficient traceability system, and operational efficiency.
TL;DR
Azumuta helps medical device manufacturers build quality in for patient safety and stay audit-ready with electronic signatures and full traceability. Guided instructions and in-line quality checks support compliance with 21 CFR Part 11, ISO 13485, and FDA standards, while complete device history supports audits and investigations. It connects with ERP, MES, and equipment on one scalable platform.
Trusted by Leading Companies Like
Top Features for the Medical Devices Industry
Digital Work Instructions
Create training material and step-by-step instructions for your workers with product-specific instructions and visual aids.
Integrated and Scalable Platforms
Combine your systems with Azumuta's quality management module. Enhance connectivity and IoT integration across databases, machinery, and sensors.
Real-Time Data & Analytics
Create real-time metrics and analytics to track and monitor the production line. No need for coding! Use our out-of-the-box dashboards and reports.
ISO9100 Compliance
Sync facilities and equipment, train your staff, and ensure the right process and materials management to be fully ISO9100 compliant.
Electronic Signatures
Collect electronic signatures from key staff to keep the process moving without the need to have everyone on site to continue the batch production.
Spot Production Bottlenecks
Identify any type of bottlenecks in production with the digital and complete process capture of ERBs. At the same time, ERB’s facilitate the best digital audit trails available.
Visibility across Your Organization
Work to track and trace any problems to see if they're a one-off issue or part of a larger defect and eliminate it at the source.
Automated Routing and Escalation Process
Quickly record issues right where they occur and assign them to the right team. Avoid resolutions lags and automatically notify decision-makers and team members.
Maintenance Schedule
Implement a maintenance schedule and checklists for regulatory compliance. Ensure the machinery is always compliant and log reports to keep track of audits.
Non-Conformance Notification
Easily track & receive notifications of completed, in-progress or overdue audits, along with approvals and rejections.
Training Report
Craft tailored learning and training plans for employees. Personalize learning experiences based on individual profiles and expertise levels for optimal skill development.
Competency Matrix
Track and visualize workforce competencies, skill profiles, and training progress. Assess operator competence and define levels of expert.
21 CFR Part 11 Compliant
Ensures rigorous data protection through organizational safeguards, staff training, and integrity measures, maintaining accuracy and confidentiality throughout the data lifecycle.
SOC 2 Compliant
Our SOC 2 certificate assures the security and integrity of your production data. We prioritize confidentiality, privacy, and integrity of your data.
Quality Built for Patient Safety
In medical device manufacturing, there’s no room for error. MES enforces rigorous quality control protocols throughout production—tracking inspections, validating critical steps, and flagging issues in real time. This minimizes the risk of defects and reinforces trust in the safety and reliability of the final product.
Regulatory Readiness, Every Step of the Way
MES captures detailed, time-stamped records across all production activities. This end-to-end traceability simplifies compliance with medical device regulations like ISO 13485 or FDA 21 CFR Part 820, and makes audit preparation far less time-consuming.
Don't just take our word for it!
At Navtech, product accuracy is crucial. Azumuta has transformed how we manage complex variants, ensuring every product is built precisely to our standards.
Richard Morris
Engineering & Operations Director
Previously, as an organization, we relied heavily on the discipline of the operators to fill in the necessary production reports. With Azumuta, we can send the necessary reminders to the operators if necessary. Moreover, we can monitor in real time whether they have actually filled in the production reports at the scheduled time.
Jurgen Kuppens
Production Coordinator
With Azumuta, we can have quality checks during assembly, ensuring there’s real-time quality control. For traceability, the product order information is stored digitally, so we can quickly address customer complaints and efficiently resolve them. This two-layer system allows us to maintain our high-quality standards and provide exceptional customer service.
Joris Cuvelier
Quality Assurance Coordinator
The ability to adapt quickly to changes in work instructions has given us a competitive advantage, while the fully automated distribution of work instructions has decreased complexity and reduced errors on the shop floor. Azumuta has revolutionized our work instruction management process and made our operations more agile.
Koen Catteeu
Operations Manager
Frequently asked questions
How does Azumuta support medical device compliance?
Azumuta provides electronic signatures, full traceability, and regulatory readiness, helping you meet requirements such as 21 CFR Part 11, ISO 13485, and FDA standards.
Can Azumuta ensure quality for patient safety?
Yes. Guided instructions and in-line quality checks build quality into every step, supporting safe, reliable medical devices.
Does Azumuta provide full device traceability?
Yes. Every action is logged and traceable, creating complete production records and device history for audits and investigations.
How does Azumuta help with regulatory audits?
Standardized, documented processes keep records audit-ready, so you can demonstrate compliance at any time, every step of the way.
Can Azumuta integrate with our existing systems?
Yes. Azumuta is an integrated, scalable platform that connects with ERP, MES, and equipment via API and standard protocols.