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Minerva Solutions

Best Practice in the Medical Device Industry

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 satisfactory by the standardized PLM platforms available on the market today.

There is a constant pressure on medical device 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
Buisness

  • 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 to be successful practices
    from other Medical Device companies who already did an
    implementation with Minerva

 

Product Features

  • Deliverable driven DMR & DHF Creation
  • Rule Based Deliverable Management
  • Dynamic DMR & DHF Management
  • Automatic Baseline Creation
  • Structured Document Management
  • Dynamic Change Management
  • Change Impact Analysis
  • Advanced Lifecycle Management
  • Complete Traceability
  • Supply Chain Collaboration

Medical Device PLM in action

Best Practice in the High-Tech Industry

Minerva Electronic PLM is tailored to handle the complex challenges of running a modern Electronics & High-Tech (EHT) company. The solution is ready to go, but still highly configurable to fit any specific customer needs.

Operating in an industry driven by innovation requires a high level of efficiency of processes and responsiveness to the new technologies in the niche. Complying with highest safety standards, product documentation requirements and keeping track of latest documentation revisions are daily disciplines for many businesses. The industry price sensitivity and strict regulatory legislations require the right tool to smoothen information flow and to manage both internal and external product-related processes in the best possible way.

Key Values for your
Buisness

  • Save time on preparing and conducting audits
  • Improve time-to-market for all products
  • Gain benefits from including Supply Chain partners in your processes
  • Improve visibility and cut cost by simplyfing the system landscape
  • Quick implementation due to preconfigured system
  • Benefit from a subscription based solution instead of a
    traditional license model
  • Take advantage of proven and successful practices
    from other electronic & high tech companies

Is this how you work?

Product Features

What if you tangle this mess by using:

 

  • Easy to use Import tool for parts, BOM and AML
  • A strong EHT data model based upon Minerva’s extensive experience with PLM in EHT
  • Out of the box Change Management with
    built in Business Logic for workflow routing ECR, ECO, DCO, MCO
  • A strong security model for easily granting access to external partners
  • Office integration
  • Export tool to provide a standardized format for communication of Product Data with external parties
  • Free viewer to open, investigate and retrive data from the export packages

Customers share their experience with Minerva

Check how other companies have benefited form implementing Minerva Solutions

Case Study: Auditdata

Faced with the challenge to find documents and to make relationships between them, Auditdata needed relation database, that would systemize documents and give a good overview of the relationships between different files.

Case Study: Malvern Instruments

1 million files, that was roughly the amount of data scattered in literally every virtual corner of Malvern Instruments' organization - from hard drives to e-mails and floppy disks. The vast quantities of unstructured information were the main factor behind their decision to find a system enabling a more structured way of centralizing the data.

Case Study: Airbus

The flexibility and scalability of Aras, which allows the user to add customized functionalities without extra charges nor any need for heavy programming, was one of the main reasons why Airbus chose to implement the system.

Read how other organizations have benefited from implementing Minerva Solutions