leap:up GmbH
About us
leap:up GmbH (formerly biosaxony Management GmbH) is a life science enabler empowering founders, startups, and SMEs to transform innovative ideas into market-ready solutions. We support innovation, market entry, commercialization, and growth across the life sciences by creating optimal conditions for breakthrough technologies that protect and improve life on earth. Our services include acceleration and development programs, training and events through our in-house academy, hub development, and access to our own co-working lab in Leipzig. With expertise spanning diagnostics, cell and gene therapy, radiopharmacy, smart medical devices, robotics and AI, digital health, and phage therapy, we actively help our partners turn scientific excellence into sustainable economic success. Regionally anchored in Leipzig and Dresden and internationally oriented, leap:up bridges the gap from scientific theory to entrepreneurial practice. Turning ideas into tomorrow’s reality.
Address
Deutscher Platz 5C
04103 Leipzig
Germany
E-mail: bianca.kretschmer@leap-up.com
Phone: +49 341 2120-719
Internet: www.leap-up.com/
Contact person:
Products & Services
Comprehensive services for medical technology, biotechnology, and healthcare industries worldwide:
3D-Printing
Clinical cooperation
Consulting
Product development
Regulatory affairs
Learn more about our Services: https://www.leap-up.com/services
medical:forge Leipzig by leap:up is an accelerator program tailored to the needs of early-stage medical technology startups aiming to enter and scale in the German healthcare system. Our customized 12-month program supports you with industry-specific infrastructure, expert guidance, and direct access to clinical and regulatory networks.
Through our strong partnerships with hospitals, health insurers, research institutions, and experienced medtech companies, you benefit from exclusive market insights and real-world validation opportunities.
Learn more about our Accelerator medical:forge: https://www.leap-up.com/projects/medicalforge-leipzig
medical:forge LEIPZIG
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!
Regulatory Affairs Services for Life Sciences
Establishment of a quality management system according to ISO 13485:2021
Document Review according to MDR 2017/745 or IVDR 2017/746
Provision of external Person Responsible for Regulatory Compliance (PRRC) / 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
