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EU MDR Gap Analysis and Assessment for MDD to MDR Transition

The 2017 publication of the new European Union Medical Device Regulation 2017/745 (EU MDR) introduced major compliance headaches for manufacturers.

Even for seasoned regulatory professionals, understanding the impact of EU MDR 2017/745 is not easy. We know, because we have trained and advised dozens of medical device companies and their employees on the EU MDR. This experience has given us a very good sense of the challenges ahead.

While the changes seem daunting, a critical first step is to understand your current level of compliance with the regulation. We can help. An Oriel STAT A MATRIX EU MDR readiness audit – which can be targeted or comprehensive – provides the clarity you need. The resulting output is an EU MDR Transition Action Plan that documents necessary tasks, resources, and timelines to address identified gaps.

Our gap assessment of your compliance with EU MDR 2017/745 includes:

  • Classification of current device(s) and whether it has changed
  • Robustness of technical documentation files and linkage to design history files
  • Clinical evaluation reports (CER) and literature reviews
  • Risk management files and procedures
  • Status of existing testing to current standards
  • Postmarket surveillance processes
  • Economic operator agreements
  • Procedures for managing your supply and distribution chains
  • Product life-cycle management
  • Labeling changes that may be required
  • UDI compliance needs

We can help you tackle areas in need of immediate attention.

Once gaps have been identified, we can help you close them one at a time, focusing on the areas that pose the greatest risk and impact on compliance. Our team has extensive hands-on experience in assisting medical device companies, and this experience covers a wide variety of device categories. We understand the challenges you are facing and can assist you in getting to a state of readiness quickly.

Let us help turbocharge your EU MDR compliance efforts. Contact us today about conducting an MDR gap analysis.

Select a course below to learn more or to register.
 
Course Name Public On-site
New!   CER (Clinical Evaluation Report) Training for EU MDR Compliance
EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)
EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)
New!   EU IVDR Transition Training (Europe’s In Vitro Diagnostic Regulation 2017/746)

Learn all aspects of clinical evaluation from planning to postmarket clinical follow-up so your CERs can withstand Notified Body scrutiny. Click to learn more.

Designed for experienced auditors who need to perform internal and supplier audits to the EU MDR requirements. Click to learn more.

Learn the latest in EU MDR interpretation gleaned from our work with Notified Bodies, EU thought leaders, and device organizations making the transition.  Click to learn more.

Learn key changes between IVDD and IVDR, discusses how to make the transition, learn best practices for transitioning. Click to learn more.

Get answers right now. Call 1.800.472.6477

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