For a market-leading company in the field of digitalr Supply paths DiA42 took on short-term and project-related tasks in the hospital IT environment. We represented the client vis-à-vis third party project partners and provided support with the Clarification of technical and regulatory contextsespecially at the interfaces between specialist departments and technology. On the basis of analyses and documentation of existing IT infrastructures Integration scenarios developed with special attention to Interoperability (KHZG; KIS; IHE/ HL7v2/ FHIR/ ISiK), information security and data protection.
The workshops were commissioned by a large application-oriented research organisation that researches and develops digital medical products. The use of innovative AI-supported processes plays a particularly important role here. The challenge is to take into account the requirements regarding quality management and documentation of software development as early as the research project stage to such an extent that subsequent commercialisation as a medical device is possible in principle.
DiA42 organised two workshops for the research facility's employees to address these specific challenges. Prof. Dr Jens Geißler explained the connection between risk classification and approval procedures, gave an overview of the required documentation and placed this in the context of research projects. Marco Wagner presented the software life cycle for medical devices in accordance with IEC 62304 and specifically addressed the individual steps of the software development process. In both workshops, the content presented was discussed and deepened with reference to the specific research projects.
Dear Mr Wagner,
We are pleased about the successful cooperation with you and your company. You have helped us a lot to bring our ideas into the concrete implementation phase!
A big thank you and a 100-% recommendation from us,
Best regards, Ingo Buckert
Training. Coaching.Speaking.
Together with a provider of seminars on preventive health, we designed and developed a digital health product to complement its service portfolio. According to the "Leitfaden Prävention" (Prevention Guidelines) of the GKV Spitzenverband, ISO 27001, ISO 27034 and EN ISO 9241 played a very special role, in addition to the obligatory requirements for e.g. data protection.
The digital product will be a Approval with the ZPP - Zentrale Prüfstelle Prävention, thus being included in the catalogue of benefits of the statutory health insurances and reaching pot. several million insured persons.
Prof Dr Jens Geißler is an excellent speaker. His presentation and moderation style encouraged active participation and insightful discussions. His overviews of reimbursement channels for medical devices were very well structured and understandable.
We look forward to working with you in the future. Best regards, Stephanie Randel
As part of an incubation programme for spin-off projects in the healthcare sector, DiA42 held a workshop on the reimbursement of medical products in the German healthcare system. The workshop pursued a participatory and product-orientated approach. The participating start-up projects developed their own reimbursement concepts under methodical guidance, which were then discussed and evaluated together. This reference to specific products made it possible to develop individual options for reimbursement channels by different funding organisations.
The workshop was prepared and moderated by Prof Dr Jens Geißler, Managing Director of DiA42 GmbH. Prof Geißler also gave an overview of reimbursement channels for medical devices in Germany. He also presented the challenges of market access procedures and reimbursement channels in other European countries, the USA and China.
Many thanks for the top cooperation and the very good performance.
Keep up the good work and best regards from Cologne, Ingo Buckert
In cooperation with a medium-sized provider of digital and analogue healthcare products, we have developed a digital medical device of risk class 1 in accordance with the specifications DIGA-The concept and development of the MDR, ISO 13485 and other referenced standards is based on the guidelines of the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte/BfArM). From the start of development to the start of the clinical trial to prove the efficacy of the product took only about 10 months!
Since we have a accredited certified information security management system according to ISO 27001 incl. 1st/ 2nd/ 3rd level support, we also operate this digital medical product and thus relieve our partner of all operational tasks.
The collaboration with DiA42 was extremely professional and solution-orientated. In addition to collaborating and coordinating the preparation of the application, DiA42 also contributed considerable expertise in the field of medical devices and thus perfectly complemented the consortium.
We are pleased that we will remain in contact even after the application has been submitted and will hopefully continue to work together successfully in the future.
In the Role of the project coordinator and applicant we have been working on an application for a Federal Ministry of Education and Research funded project. Other project partners included a Fraunhofer Institute, one of Germany's largest university hospitals, two other university partners and a software company. The content of the funding application was Development of an innovative digital medical device using VR technology.
We were actively involved in the conceptualisation of the research proposal. The focus of our contribution was
The result was a Research proposal submitted on time for a three-year research project with a scope of more than 160 working months and a volume of approx. 2 million €.
Nutze unseren KI-Bot, um gezielt Fragen zu diesem Dienstleister zu stellen, Inspiration für dein Projekt zu sammeln oder passende Alternativen zu finden. Schnell, einfach und rund um die Uhr für dich da!
Comment
Working with DiA42 was an extremely positive experience. We have been impressed by their expertise and adaptability in the areas of sales engineering and eHealth. Particularly noteworthy is their ability to make complex technical issues understandable and accessible, which is invaluable to our customers. The attention to our customers' data protection requirements and the guarantee of IT security confirm their commitment to quality and security. DiA42's willingness to support us in various aspects of the sales process, as well as their extensive knowledge of public tenders and project management, make them an indispensable partner for us. We look forward to continuing this fruitful co-operation and are confident that it will help us to achieve our goals in the healthcare sector.