EU MDR and EU IVDR Implementation

We are utilizing our Project Management, Medical Devices, and In Vitro Diagnostic expertise to support our clients' efforts in following the updated regulations

The First Phase of the EU MDR is Required to be in Effect by May 2021 — Are You Ready?

(MDR 2017/745) will impact how medical devices are regulated and monitored in the EU. This will bring changes such as:

  • Reclassify devices and assess impact on revenues and margins
  • QMS impacts, increased notified body powers, key regulatory resource accountable
  • Enhanced traceability, UDI systems, assess impacts to economic operators
  • New clinical investigation and evaluation regulations
  • Enhanced post-market surveillance and vigilance processes
  • Change in label requirements, instructions for use requirements, and impacts to packaging

We Can Build the Structure - We will create a PMO structure to successfully drive your EU MDR effort. Our team will work with you to define "done" for the effort, develop project plans for each workstream, drive project progress, and keep all of the teams closely aligned.

We Have the Expertise - We have successfully and efficiently driven our client through all of these activities and are currently awaiting to complete the notified body audit (upon their certification). Our team can build quality documents and update your medical device manuals.

We Have the People - We bring Project Managers who are versed in EU MDR, core project management leadership, medical devices, and Quality/Regulatory principles. Our subject matter experts have deep, cross-functional knowledge.

You shouldn't have to figure out EU MDR alone. At Treximo, our experts can help you navigate the changes in regulation..

The First Phase of the IVDR is Required to be in Effect by May 2022 — Are You Ready?

(IVDR 2017/746) will impact how in vitro diagnostics are regulated and monitored in the EU. This will bring changes such as:

  • Reclassify in vitro diagnostics and assess impact on revenues and margins
  • QMS impacts, increased notified body powers, key regulatory resources accountable
  • Enhanced traceability, UDI systems, assess impacts to economic operators
  • Enhanced diagnostic test performance requirements
  • Increased expectations and requirements for post-market surveillance and vigilance processes
  • Updates in label requirements, instructions for us requirements, and packaging impacts
  • Increased involvement of notified bodies

We Can Build the Structure - We will create a PMO structure to successfully drive your IVDR effort. Our team will work with you to define "done" for the effort, develop project plans for each workstream, oversee/drive project progress, and keep all of teams and key stakeholders closely aligned.

We Have the Expertise - We have successfully and efficiently driven our clients through all of these activities and are currently awaiting to complete the notified body audit (upon their certification). Our team can build quality documents and update your medical device manuals.

We Have the People - We bring Project Managers who are versed in IVDR, in vitro diagnostics, core project management leadership, and Quality/Regulatory principles. Our subject matter experts have deep, cross-functional knowledge.

You should not have to figure out IVDR alone. At Treximo, our experts can help you navigate the changes in regulation.

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What Does Engagement With Treximo Entail?

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We will utilize our diagnostic tools to assess your current activities and assess deliverables (as needed). Our team will then identify gaps and prioritize strategies to enhance your current EU MDR and In Vitro Diagnostic Regulation implementation. Schedule a consultation today to receive a brief screening phone call, get connected with the appropriate team member for your specific needs, and receive a highly-detailed plan of action.

What are high performing companies doing with their implementations?

Based off of our experience, our top-performing clients are doing the following very well:

  • Strong Project Management structure to successfully drive the implementation and maintain project timelines.
  • Clear and Defined Ownership to ensure new/updated processes have proper roles and responsibilities defined.
  • Strong Industry Awareness to updates or additional clarification to regulatory guidance.
  • Strong Collaboration between functions, partners, and other key stakeholders to ensure on-time delivery and proactive management of issues.

Are you performing like your peers?

Take Your Projects to the Next Level with Treximo.