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.

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.

Don’t just take our word for it!

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

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Don’t just take our word for it!

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

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Don’t just take our word for it!

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

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