BIO International Convention 2025German Exhibitors leap:up GmbH

leap:up GmbH

www.leap-up.com/

About us

leap:up GmbH – The Life Science Enabler

leap:up GmbH (formerly biosaxony Management GmbH) empowers founders, startups, and SMEs in the life sciences to take significant steps towards innovation, market entry, commercialization, and growth.

"leap:up" stands for bold leaps into the future of life sciences. As a life science enabler, we create optimal conditions for the realization of groundbreaking ideas.

Our portfolio includes acceleration and development services for life science projects, regulatory support, training programs, and events through our in-house academy, as well as the provision of state-of-the-art co-working labs in Leipzig. We are actively expanding our international presence and service, including investor relations and funding opportunities.

Our focus areas include diagnostics, cell and gene therapy, radiopharmacy, smart medical devices, robotics and AI, digital health, and phage therapy.

Local work is strengthened by leap:up’s two offices in Leipzig and Dresden.

BIO CITY LEIPZIG is the heart of the BioCity Campus - a centrally located commercial area exclusively dedicated to life science companies and research institutes, offering over 25,000 m² of lab and office space.

leap:up Team

leap:up stuff during post processing of PA12 components (HP JetFusion) in the 3D printing lab at MedicalForge Leipzig Coworking space

leap:up stuff feeds PA12 components (HP JetFusion) into the machine for surface finishing

leap:up stuff pipetting in the lab

Regulatory Affairs Team

Address

leap:up GmbH
Deutscher Platz 5c
04103 Leipzig
Germany

E-mail: andre.hofmann@leap-up.com
Phone:  +49 176 17965501
Internet: www.leap-up.com/

Contact person:

André Hofmann
CEO
E-mail: andre.hofmann@leap-up.com
Phone: +49 176 17965501

Dr. Maike Rochon
Head of Strategy & Innovation Management
E-mail: maike.rochon@leap-up.com
Phone: +49 162 6051800

Products & Services

Biotechnology
Cluster Healthcare Industries
Consulting
Medicine / Pharmaceutics
Incubator / Technology Park

The MEDICAL FORGE LEIPZIG supports startups and innovative companies to bring their medical products faster to the German healthcare market. The customized 12 months program focuses on the specific needs of young medical technology companies.

Our extensive network including hospitals, health insurances and experienced industry partners will provide you with invaluable insights and project opportunities.

We offer you an in-kind service bundle with an overall value of 185,000 Euro including coworking laboratories, offices and electronic workshops, as well as personal consulting, mentoring, and much more. You have to provide 21,000 Euro of your own capital. However, you will receive a 25,000 Euro team budget during the program.

Forge your way to the healthcare market with us!

MEDICAL FORGE LEIPZIG

Visit website

MEDICAL FORGE LEIPZIG

Consulting

  • Site Marketing – national, international

  • Market Research & Market Access

  • Project Acquisition & Financing

  • Strategy & Finance, Investor Relations

Networking & Cooperation

  • Networking Events

  • Business Matchmaking

  • Contact Initiation

  • Establishment of Strategic Partnerships

  • Representing your Interests at  Partnering Conferences

Regulatory Affairs Services for Life Sciences

  • Establishment of a quality management system according to ISO 13485:2021

  • Document Review according to MDR 745/2017 or IVDR 746/2017

  • Provision of external Person Responsible for Regulatory Compliance (PPRC) / Quality Management

  • Representative (QMR)

  • Provision of an authorised representative (EC-Rep) mandatory for manufacturers of medical devices /in-vitro diagnostic devices based outside the EU, with tasks such as:

    Review of the issued EU Declaration of Conformity and the corresponding conformity assessment procedure

    Review of the up-to-dateness of the technical documentation

  • Contact person for national authorities Review and advice on specific topics such as:

    Risk Management | Clinical Evaluation |Usability

    Software Lifecycle | Post Market Surveillance

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