Blockchain technology is not only an attractive way of payment for the financial sector, but it is also becoming increasingly important in the health sector. Thanks to steadily increasing digitalisation, a growing number of digital health applications are coming onto the market. Secure exchange of sensitive data is a top priority here. For the health sector, blockchain technology offers very special application possibilities. Secure solutions can be implemented for the management and exchange of sensitive health data. In addition, security and traceability within supply chains, for example of pharmaceuticals, can be significantly increased.
Start-ups and small and medium-sized enterprises are the real drivers of innovative solutions in the health sector. However, they often lack the financial and human resources to implement new technologies in their processes. On top of that, the legislator imposes high regulatory requirements on the manufacturers of medical devices. Introducing new technologies into this sector is therefore extremely work-intensive.
Are you planning to place a digital health app or medical software on the European market and considering the usage of blockchain solutions, but struggling to navigate through the regulatory jungle? Take advantage of our Blockstart SME training programme, which provides a multitude of courses related to blockchain technology and business development covering the healthcare, logistics and agrofood sector.
For the health sector, we offer individual courses tailored to your specific needs in developing your medical device. Our Blockstart partner, Schrack&Partner, will guide you through all the pitfalls of medical device development and work with you to clarify regulatory requirements for your new health solution. You will receive several thousand euros worth of courses for free. For EU SMEs who want to test the impact of BC technology in their company, these courses offer an exceptional opportunity.
For a general overview of the MDR, the “Regulatory Basics and Medical Devices in Europe” course is the ideal entry point. You will learn how to set up a well-functioning quality management system. To do so, you should know what a medical device in Europe is in general and what you need to do to achieve the necessary qualification and to identify the right conformity assessment procedure. Furthermore, you should also be familiar with the required technical documentation in order to place your medical device on the European market. The course addresses all these questions and many more.
To get some details about the content of the “Regulatory Basics and Medical Devices in Europe” course, watch the video.
Likewise, risk management for the placement of medical devices in the EU market is a requirement you need to fulfil as a manufacturer of medical software and digital health apps. In the course "Basic Risk Management for Medical Devices" you will learn the basics of risk management as well as strategies for risk mitigation and procedures for risk analysis.
You can find out more details about the content of the course "Basic Risk Management for Medical Devices" in the video.
To avoid unexpected surprises when placing your medical device on the market, you should take a critical look at design and development at an early stage. In the course "Medical Device Design and Development", which has a specific focus on software, you will learn all the requirements for your medical device design, including software as a medical device in the EU market and its life cycle according to EN 62304, change management, clinical evaluation and design validation.
Watch the video for more details on the content of the course "Medical Device Design and Development".
Further application possibilities tailored to your specific needs are offered by our partner Michael Munz Blockchain-Technologieberatung, who has profound experience in the development of BC-based solutions and the requirements and possibilities in the German healthcare sector. In three courses with different approaches, you will gain a basic understanding of blockchain. In addition, you will be introduced to various use cases that contribute to more efficient data processing for your specific case, e.g. reduction of paperwork, exclusion of middlemen for data transmission and many more.
Module A: Blockchain basics for the Healthcare Industry
Module B: Deep Dive - Blockchain in the Healthcare Industry
Module C: Business Development Workshop: How to identify and define suitable business cases for the Healthcare Industry
Interested? Apply for our free Blockstart SME Training Programme today!