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Carestream Health requirements:

Carestream Health had a very clear understanding of what they wanted in a system – the system should support the specific requirements that medical device companies must adhere to. In addition, the ability to link data elements together – to create a Product Level Information repository – was top of the priority list for Eli Tuber.

Other specific requirements were:

  •  Support of the Design and Development Plan

(DDP) that contains documents for design inputs and outputs, design review, design verification and validation, design transfer, regulatory and several others.

  • Project management functionalities like Project Record that allows project definition and the Deliverable Matrix that defines all the deliverables associated with the project phases.
  • Document change management and PLM driven change control
  • FDA Title 21 CFR Part 11 compliant document structure.

After using the Minerva Medical Device PLM for several years, Carestream approached Minerva with some productivity enhancement requests.

After agreeing on the requirements, the project team at Carestream Health and at Minerva held two discovery sessions to clearly understand every aspect of the requirements and to map out implementation strategies. Using an Agile sprint implementation methodology, the project team at both ends started building the solution.

Background:

Carestream Health is an internationally successful leader in medical imaging systems and healthcare information technology solutions. Carestream products can be found in 90 percent of hospitals worldwide.

The company delivers scalable solutions for every step of the diagnostic imaging process, from exam ordering, image capture and diagnosis to results distribution, billing and beyond to customers across the globe. Among its products, is digital medical solutions, medical film and printing solutions as well as high-quality products for a wide range of industrial applications for non-destructing testing.

Carestream employs more than 7.300 employees across North America, Europe, Middle East and Asia.

In 2016, the Minerva Medical Device PLM solution was implemented to improve Project Management, especially improving the management of deliverables for both medical and non-medical device projects. After migrating a vast amount of data from the former Lotus Notes platform into Medical Device PLM, now Carestream Health has all their DHF information inside the Aras platform.

 

 

In the full version of this case study, you can read how the Minerva Medical Device PLM solution was implemented to improve Project Management, especially improving the management of deliverables for both medical and non-medical device projects.

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