Ensyme- The Venture Lab
Office in Tübingen, Germany
The Corporate Venture Builder of tomorrow´s digital health market leaders
Ensyme is HPZenner´s digital medical device company builder. Beautyfully located in Tübingen, Germany, with its University of Excellence and situated in Germany´s Medical Device Valley Ensyme builds, and partners. Financing may be supported.
For founders or spin offs.
HPZenner´s Ensyme is a highly specialized corporate venture building platform for founders or spin offs wishing to develop, produce and distribute CE marked DTx. Companies may be de novo start ups as well as spin offs.
Corporate development, marketing and scaling.
HPZenner takes an active role in the development, marketing and growth of your newly founded company.
- We help you to establish your quality management systems acc. to ISO 13485 and 27001
ISO 13485 is a harmonized standard that formulates requirements for the certification of the quality management system (QMS) that is required by all medical device manufacturers. With the help of the ISO 27001 certification, the manufacturer fulfills an essential requirement for a DiGA approval. We help you to produce the required quality manuals. Manuals must describe the quality objectives and quality policy. Furthermore, we offer you basic seminars on ISO 13485 and ISO 2700 or a seminar for internal auditors
- We can help you to set up your start-up in accordance with the regulatory requirements.
ISO 13485 and 27001 strongly influence your corporate governance. We help you to set up the processes and structures required by the regulatory authorities.
-Internal auditing
We may perform your internal auditing
Our Capabilities.
To this end, HPZenner Ensyme has established an interdisciplinary expert team of venture capitalists, business developers, digital engineers, regulatory affairs managers and clinicians that drives the development of the startup forward and supports the founding team. This may include software development, clinical contents development, TD according to MDR, ISO 13485 and 27001 certification, EU market access including CE marking according to MDR, and BfArM registration including Clinical Trials according DVG and DiGAV.
Applications are welcome anytime.
Do not hesitate to contact HPZenner´s Germany office via office@hpzenner.com (phone: +49 7071 49645) or HPZenner´s UK office via london-office@hpzenner.com (phone +44 7981 859 404)