Global Roll-Out of EU MDR Implementation​

Global Roll-Out of EU MDR Implementation

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Project Teams
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Technical Files
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Global Locations

Objectives

  • Develop a global approach for the implementation of the EU Medical Device Regulation across seven locations
  • Develop a governance model and program structure that was standardised and scalable across seven global sites
  • Develop standard toolkit to facilitate remote and group collaboration
  • Reduce the management burden of the program as internal staff are heavily loaded
  • Provide live accurate transparent measurement of progress
  • Bring the program to stable execution before transition
  • Transition: hand over the management of the program to the internal team

The Challenges

A global manufacturer of medical devices is obligated to comply with EU Medical Device Regulation 745/2017 in order to maintain their products on the European market.

While the organisation had a strong quality and regulatory knowledge, they did not have the experience to bring a global program of this magnitude through the necessary assessment and planning phases and into execution.

A Common Approach

A standard approach with easy-to-use, transparent tools was developed including:

  • Trinzo gap assessment tools
  • Trinzo work breakdown structure template
  • Trinzo status update report
  • Trinzo EU MDR progress and compliance tracking database

Overview of Project Phases

We worked with these clients to break down the project into three concise phases. We started by assessing the initial state of the business in relation to what was needed for MDR compliance. We used a variety of simple tools (see toolkit below) to assess how far the client had progressed prior to the start of the project and also identify what deliverables were needed in order to meet MDR compliance.

We used a simple, strategic and effective project management process to aid in scoping out work to be completed, resources to be allocated, budget to be tracked and over project status to be communicated. We maintain a confident, supportive and collaborative approach to project management that allows complete clarity and visibility of the project from the teams to project leads and upper management.

The Trinzo Apex Approach to Managing an MDR Project

  • Base the initial State
  • Build structure
  • Launch – move to planning
  • Work package deliverables
  • Work breakdown structures
  • Detailed project plan
  • Resource plan
  • Stakeholder analysis
  • Sign-off charter
  • All project teams move into execution
  • Project teams report on progress

Project Timeline

QA
2018
Pilot
  • EU MDR Interpretation
  • EU MDR Gap Assessment
  • Setup Project Teams
  • Resource Teams
  • Develop WBS per team
  • Charter teams
FEB
2019
Launch Workshop
  • Global Support Identified
  • Global Project Reams - 11
  • Site Program Standardised
  • IT Projects - 14
  • Total: 97 Projects
Q2
2019
Gloabal Planning
  •  Resources Assigned
  • Team Objectives
  • Charters Developed
  • All teams moved into Execution Phase
  • 255 Team Members
Q3
2019
Global Execution
  • Notified Body Transition
  • MDD Exstensions
  • Global Policies drafted
  • Auth.Rep Office Setup
  • PMCF plan development
Q4
2019
  • Global Policies (21 Policies)
  • Training for Global Policies
  • IT System Updates
  • Global Team Closure
  • PM Team Transition
MAR
2020
  • Local Site TeamQMS' MDR Compliant
  • PMS / PMCF Plan
  • All Global teams closed
  • EU Auth.Rep Audits
  • PM Team fully Transitioned
JUN
2020
Transition to MDR
  •  Products begin to Transition to MDR
  • Deliverable tracking ongoing
  • Compliance tracking
MAY
2021
Internal team continue to move towards full transition

Result

All change orders completed with zero findings on MDR readiness audit

€450K ahead of budget

233 project team members engaged and mobilised

87 project teams initiated, planned, and moved into successful execution

Graphical toolkit utilised to facilitate remote and group collaboration

Global EU MDR program successfully moved to stable execution

8 Months - start to execution phase

What I liked about Trinzo was the fact that they provided a very practical approach that was sensitive to the challenges of running a business. The team and people selected were also a great fit ... I would have no hesitation in recommending Trinzo as a partner to work with.