Navigating Medical Approval for Hearing Devices

Requirements, Challenges & Best Practices

Join us for a practical webinar bringing together audio and hearing industry experts to share insights on regulatory pathways, medical approval, and market access for audio and hearing-related products – with a special focus to inspire startups and small to mid-sized companies looking to launch in the medical field.

Now’s your chance to ask all of your questions to people who´ve travelled the path of medical approval themselves.

Date: 22 September 2026

Time: 14.00 CET

Format: Webinar

Price: Free

Language: English

For you interested in:

Audio Products

Hearing Devices

Hearing Health

Agenda

Karen Bryde Frisk

Early product development, Intended Use/Purpose, and key considerations when initiating regulatory strategy

Thomas Krohn
Overview of the regulatory landscape, including differences between EU and US frameworks, and high-level risk considerations

Kai Harrekilde-Petersen
Clinical need, business models, and common pitfalls for early-stage companies

You Will Meet

Karen Bryde Frisk Director of Regulatory Affairs at GN Group

With nearly 20 years of experience in global Regulatory, Quality and Clinical Affairs across medical devices, hearing solutions and diagnostics, Karen has held leadership roles at GN Hearing, Thermo Fisher Scientific, Medtronic, ConvaTec and Unomedical, covering everything from complaint handling and vigilance to global product registrations and regulatory strategy.

Karen is passionate about building strong RA/QA teams and using regulation as a driver for safe innovation and sustainable business growth.