Digital QMS for Medical Devices

Implement a Digital Quality Management System in your organisation to improve efficiency, compliance and overall product quality.

As a Medical Devices company, you help improve health and quality of life by innovating and accelerating high-quality research.

Implementing a Quality Management System, like ISO 13485, helps you to organise and link numerous processes.

In Bizzmine you can easily digitise and automate these quality processes: Document Control (SOP), Management of Technical Files, Internal and External Audit Management, Risk Management, Corrective and Preventive Action (CAPA), Non-conformance Management, Post-Market Surveillance, Complaint Management, Incident Management (Vigilance), Calibration Management, Management of Change (MoC), Training Management, Design Control.

With Bizzmine, we feel that we have a secure and homogeneous environment to maintain, order, and standardize our ISO documents. The software really helped us get through our process of becoming ISO certified in a short time and with less work.

- Tiki Safety

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With Bizzmine you have validated QMS software according to GAMP5 standards.

These certifications can help you improve overall performance, eliminate uncertainty, and widen market opportunities.

The validation of your Quality Management System can be easy if you rely on our eQMS prebuilt validated processes.

And as your business grows, so must your quality management. A digital QMS can scale to meet increasing documentation, processes and requirements.

For Staxs, Bizzmine is the best of both worlds: the software fully meets our ISO and GMP requirements without being too complex.

- Staxs
15 key Digital QMS essentials for Medical Devices
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Audit Management

Bizzmine helps you to better organize and follow up your internal and external audits.

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CAPA Management

Bizzmine helps you to continually improve the effectiveness of your QMS.

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Training Management

Bizzmine helps you to better manage and control all data on training and competencies.

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Complaints Management

Track, investigate, and correct your customer and supplier complaints. 

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Calibration Management

Bizzmine is the perfect application to plan, organize and analyze all calibration processes.

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Document Control

Centralized management of SOPs, manuals, work instructions and other documents.