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.