CE-marking and FDA approval grants access for your medical device into the European Union and the United States respectively.

Our experts have deep knowledge of the regulatory requirements and processes of Notified Bodies which enables us to plan and implement appropriate strategies for obtaining the approvals.

Our services include:

  • Product classification and selection of suitable procedures for product conformity assessments

  • Compilation of Technical Documentation

  • Compliance check with Essential Requirements

  • Selection of Test Laboratories, Notified Bodies and relevant coordination activities

  • Definition and admission of combination products

  • Support on market surveillance for your products and establishment of an appropriate vigilance system for your products

Get in touch to find out about your route to regulatory approval and how to get there in the shortest time possible. 


AMBIO Healthtech international expert team is offering a unique opportunity to receive individual advisory for preparing you for your next funding round. Either you are getting ready for a seed investment or later fundrasing stages, our experienced industry investors, pitch coaches and legal experts will guide you in your effort, with dedicated hands-on support on essential matters. You can pick and pay for different service blocks, depending on your individual need.

This package includes hands-on expert support and consulting on:

1. Fundrasing fundamentals- investor thesis, criteria and requirements*, preparation for fundrasing rounds.  

2. Effective pitch: content, design and convincing presentation techniques

3. Negotiating with investors from the legal perspective: term sheet, shareholder agreement, post deal governance etc. 

    *Upon individual request, we also perform business plan analysis, cost-benefit modelling and review of other documentation that investors require.

    Get in touch to find out more.


    At AMBIO Healthtech we are committed to- and strongly believe in expanding the entrepreneurial mindset and in enabling the transformation of ideas into real business opportunities by providing access to necessary skills, knowledge and network.

    Therefore, we passionately share the knowledge and expertize with a wider audience by organizing thematic seminars, expert discussions and roundtables, startup pitch events and others. We help various private and public organizations and industry stakeholders  design their events and bring the best people to inspire and inform the audience - get in touch to discuss your needs and our ideas.


    AMBIO Healthtech team and its international network of experts and partners have gathered a significant level of expertise and experience within innovation and life science areas, and we are ready to share it with you. We consult on the essential entrepreneurship in life science topics - from business modeling, patient journey mapping, market and competitive analysis, to regulatory requirements, IP protection, go-to-market strategies an other. Reach out and let's explore how we can support you.