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Best practice

Based on more than two decades of experience in implementing PLM for the Medical Device Industry, we have developed an industry solution that handles the issues that are not solved satisfactorily by the standardized PLM products available on the market today.

There is a constant pressure on Healthcare companies to keep up with the latest regulatory legislations and at the same time to maintain optimized workflow. The fear of mismatching with regulations has forced some of them to adopt an inefficient work structure, which results in higher costs and less budget for Innovation and New Product Development.



Key values for your business

  • Save time on preparing and conducting audits
  • Improve time-to-market for all products
  • Can properly validate the system for Medical Device
    standards like 21 CFR Part 11 and FDA CFR 80
  • Store and retrieve DHF, DMR and related documentation
    much faster
  • Quick implementation due to preconfigured system
  • Benefit from a subscription based solution instead of a license model
  • Take advantage of proven practices from other Medical Device companies who already did an implementation with Minerva

Medical Device PLM in action

Auditdata develops digital hearing instruments and software solutions for hearing professionals. The  company suffered from inefficient data management, lack of visibility and time consuming change control and DHF/DMR management.

The Minerva Medical Device PLM solution solved Auditdata's challenges including:

  • Improving the flexibility, which allows easy harmonisation and integration with other enterprise systems.
  • Dramatically shortened the Time-to-change order - from days to minutes
  • Better visibility and understanding of data relationships
  • Improved documentation search process
  • Made online collaboration within Auditdata sites and outsourced manufacturing site possible

Medical Device PLM In Depth:



Medical Device PLM is designed for interoperability, critical in the increasingly collaborative and networked world of health care systems. Our solution allows you to deliver value in multi-tiered networks, while avoiding the disruption, risk and cost of a “rip-and-replace” approach.

Medical Device PLM:

  • Works across systems and functional boundaries such as ERP and provide access to mechanical and electronic designs, software, requirements, technical documentation, process plans and quality documents.
  • Leverage and extends your existing investments in ERP, PLM, and MES through application mashups.
  • Rapidly prototype and deploy medical engineering applications that monitor, manage and control connected devices.
  • Engineers independent and secure connectivity between devices.
  • Manages devices and sensors.
  • Collects and analyzes data from connected devices.

Based on our decades of systems and model-driven engineering experience, Medical Device PLM ensures all disciplines and functions are working from the same requirements and systems model. It enables the multidisciplinary development of devices that are systems of systems – integrating hardware, electronics, software and formulated components.

Medical Device PLM:

  • Allows hardware and software deliverables to be structured in the same composite Bill of Materials (BoM), ensuring accuracy at critical hand-offs like Engineering to Manufacturing.
  • Enables multiple engineering disciplines to collaborate with one another in design reviews and adhere to the same change management processes.
  • Enables traceability. It means anyone connected to the platform can select a part and instantly view the related CAD model, simulation tests, requirements, change history, manufacturing execution data and in-service field data.
  • Supports devices throughout the entire lifecycle by re-using data and connecting it via digital threads to quickly respond to inquiries during regulatory reviews, or sustaining incremental engineering changes.


Avoid the risk by leveraging and enforcing best practices for product development teams. With Medical Device PLM you will be able to manage all phases of the product lifecycle, especially the evolving product configuration and associated changes process.

This process can begin as early as the requirements and systems modelling stage, flowing through and eventually providing context for industrial internet of things (IIoT) data and supporting quality, manufacturing planning and service documentation processes.



Request Demo

Ready to see Medical Device PLM in action? Send an email for a Free Demo and get a one-on-one preview on how your Business can benefit!