Medical Device Organizations

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The Medical Device Landscape is Evolving

Over the last few years, the medical device industry has aligned with the drug and biologics industries from a regulatory standpoint, however, the development model for medical devices is very different, notably R&D is often distributed across various different organizations and being able to centralize information is key. Montrium Connect facilitates collaboration between internal and external teams and allows you to work centrally on documentation, change management and quality control.

We Know What’s Important to You!

Montrium Connect has been developed with medical device companies in mind. We are able to manage all documents and records both during the R&D and commercial phases in one central location. Predefined configurations for DHFs, DMRs and DHRs allow you to quickly start to author, collaborate and manage all documents and records. Because our solution is web-based, it is possible to work across geographically diverse teams to ensure that everyone is working on the latest version.

Meeting the requirements of ISO 13485 can be challenging and Montrium Connect has been conceived to facilitate the implementation of ISO compliant quality systems. Our quality modules integrate to provide a comprehensive solution which allows you to proactively manage quality both internally and with suppliers. All quality events can be centrally registered and then resolved in a timely manner. Metrics and KPIs give you real-time indicators on the health of your operations and the ability to proactively act on quality trends.

  • Centrally author, collect and manage DHF, DMR, DHR records
  • Proactively manage quality through our integrated quality management system
  • Controlled version and revision management
  • Improve Document Collaboration
  • Produce submission-ready documents easily

Our Solutions for Medical Device

Montrium Connect provides multiple solutions for regulated content and quality management for the medical device industry.

RegDocs Connect Automate the Collection of Submission Ready Content

RegDocs Connect – Automate the Creation of Submission-Ready Content

RegDocs Connect gives your operational and regulatory teams the tools they need to prepare complete and compliant submission ready documents and records. Built with the end user in mind, collaboration, automation and quality are the foundation of this solution.

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SOP Connect Automate the entire lifecycle of your controlled documents

SOP Connect – Automate the entire lifecycle of your controlled documents

Montrium’s SOP Connect module is designed to manage all controlled documents that form part of your quality system. Easy access, centralized distribution, intuitive workflows and strong integration with our Training Connect module ensure that quality and compliance are at the heart of your operations.

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Training Connect Facilitate the planning and completion of GxP Training

Training Connect – Facilitate the Planning and Completion of GxP Training

Training Connect facilitates the planning and completion of SOP or regulatory training. An integrated training matrix coupled with intelligent form technology allows you to track and manage employee training more efficiently, ensuring that you meet all training requirements.

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CAPA Connect Centralizing and Empowering Continuous Improvement

CAPA Connect – Centralizing and Empowering Continuous Improvement

CAPA Connect is an integrated deviation, incident and CAPA management solution which allows you to manage all of your quality events in one central location. CAPA Connect has intuitive forms and workflows which adapt based on the type of quality event being managed.

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Audit Connect Planning Audit Activities Electronically

Audit Connect – Plan and Track Internal and External Audit Activities

Audit Connect lets you define and use checklists to perform audits and record observations. Both external and internal audits and inspections can be man