Overview
Many organisations see regulatory planning as a compliance exercise. For early-stage MedTech companies, a credible regulatory and clinical roadmap can play an important role in product development, funding discussions and stakeholder confidence.
Too often, early plans are built on assumptions that have not been properly verified. A structured, evidence-based approach can help identify business risks, improve risk transparency and support investor confidence.
In this 60-minute webinar, TÜV SÜD experts will share practical considerations for developing regulatory and clinical roadmaps and explain how evidence-based planning can strengthen your business case.
What you will learn
Your regulatory and clinical roadmap is more than a planning document. It can help you identify assumptions, understand risks and support more informed business decisions.
After watching this webinar, you will be better equipped to:
- Build a regulatory roadmap based on evidence rather than assumptions
- Understand how evidence can support more informed discussions with investors and other stakeholders.
- Align regulatory planning with business objectives and investor expectations
- Understand key regulatory considerations, timelines and dependencies
Before watching, ask yourself:
- Which assumptions within your current regulatory strategy are supported by evidence?
- If evidence requirements changed tomorrow, what impact would that have on your development plan?
- Could your roadmap withstand scrutiny from investors, regulators and business stakeholders alike?
- Are regulatory decisions shaping your business strategy or reacting to it?

Who should attend
This webinar is designed for early-stage MedTech companies and professionals involved in regulatory planning, product development and investment decision-making.
It is particularly relevant for:
- MedTech founders and start-up teams
- Regulatory affairs professionals
- Product development and innovation leaders
- Investors, incubators and accelerators
- Business leaders supporting medical technology innovation
This webinar is especially useful if you are:
- Looking for early-stage investment
- Wanting to bring credibility to your regulatory strategy
- Building a business case for a new medical device
- Preparing for funding or investor discussions
- Looking to reduce risk through evidence-based planning
Meet our speakers
Moderator
Malte Knowles Schmidt - Global Portfolio Manager, TÜV SÜD Medical Health Services
Malte moderates the discussion and guides participants through key topics related to regulatory and clinical roadmap development for MedTech start-ups.
Speakers
Ralf Gansel - Head of Sales, TÜV SÜD Medical Health Services
Ralf contributes perspectives on regulatory planning considerations and roadmap development throughout the product lifecycle.
Julia Hoyer - Head of Regulatory Affairs, TÜV SÜD Medical Health Services
Julia shares insights related to regulatory planning, roadmap development, and certification planning considerations.
Continue the journey
This webinar is in a three-part series focused on helping MedTech organisations understand how regulatory decisions can be used as a business asset, not a blocker throughout their development journey.
Live webinar on 12 Nov | MedTech Software Changes
Explore the Start-up & Investors Hub
This webinar forms part of TÜV SÜD's broader Start-up & Investors Initiative, designed to help MedTech startups and investors understand how to make key regulatory decisions that impact business risks and commercialisation.