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Case

Virtual support on regulatory strategy and project management

GN Hearing A/S

Challenge

  • Project management of a portfolio of separate workstreams.

  • Regulatory strategy (MDD / MDR) not finally decided, as the Notified Body was delayed in their MDR designation, and the EU Commission postponed MDR 12 months until May 2021 due to the COVID-19 pandemic.

  • New device technology disrupter and most important new technology launch in years for GN Hearing, industry and patients.

We faced a regulatory challenge further complicated by the requirement of primarily supporting on a distance due to COVID-19.

In addition, we needed hands-on project management being able to execute and a strong commitment to deliver within agreed timelines, as a planned global launch was dependent on the CE mark of this new device.

Genau & More supported us strongly on this business-critical project and delivered on committed timeline. They delivered exactly, what they promised.

Lars Hagander
Senior director, GN Hearing A/S

Solution - Proces

  • Governance structure with C-level access, line management and project organization, incl. establishment of project dream team.

  • Virtual daily meetings with dream team members (subject matter experts).

  • Establishment for X-Point plan and identification of high-risk issues guiding attention and priorities, securing a MDD-based CE mark followed by a MDR-based CE mark (when appropriate).

  • Breakdown into action plans and actions with most responsible stakeholders.

  • Alignment and communication with Notified Body on product certification issues.

  • Fast-track remediation on product certification issues.

Results

  • CE mark on new device, Resound ONE™, a hearing aid with a Microphone & Receiver-In-Ear design and technology (M&RIE).

  • Global launch August 27, 2020 (MDD).

  • MDR approval fast-track plan and execution in close co-operation with Notified Body.

  • Input for streamlining New Product Development (NPD) process and ensuring earlier technical documentation readiness.

#MedicalDevice #VirtualSupport #Covid-19 #Strategy #NotifiedBody #ProjectManagement #CE-mark

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Simon Bagger

Senior Consultant and Manager, IT & Automation
IT & Automation / GAMP, Project Management, GMP, Computer System Validation

Henrik Johanning

CEO & Senior Consultant
IT & Automation / GAMP, Project Management, Management Consulting, GMP, Regulatory Affairs, Training