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Logo von DiA42 – Gesellschaft für digitale Medizinprodukte mbH

DiA42 - Society for digital medical products mbH

Hospital Futures Act, Managed Services, Cyber-Security, Software Development, Digital Transformation
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Unternehmensdarstellung

Design, development and operation & support of digital medical devices (Software as Medical Device/ SaMD) according to ISO 13485 (QM system), ISO 14971 (risk management), ISO 27001 (information security), IEC 62366 (usability), IEC 62304 (software life cycle), IEC 81001-5-1 (cyber security), GDPR/ DSGVO (data protection), MDR (Medical Device Regulation) ### for specialised service providers, clinics, pharmaceutical companies and medical technology manufacturers: Do you have ideas for digital therapy or prevention products, but don't want to get bogged down with regulation or IT? Would you like to test your future product as part of clinical trials, for example? Focussing on your core competence and fast market access are more important to you than doing everything yourself? We would be happy to be your partner in the development, authorisation and/or operation & support of your digital idea, e.g. as a digital medical device, test product, DiGA or as a ZPP-certified digital prevention product. ### for IT service providers: Do you lack the necessary certifications and processes to work for your customers in accordance with Medical Device Regulation or to implement a Secure Software Development Life Cycle? Then let us organise your project together in a regulatory compliant manner, from conception and development to operation and support: with your development capacity, our processes and without you having to go through the time-consuming certification process yourself! Or would you like to tap into the market yourself and make progress on your own? Use our certified processes and templates and let us set up your own ISMS according to ISO 27001 or QMS according to ISO 13485 together! ### for research institutions & consortium projects: Do you want to bring innovative treatment methods to patients with your project, but your consortium still needs a project coordinator, advisory board for subsequent commercial exploitation, partners for regulatory affairs or for implementation? We are that partner and will work with you to make your project a success! PS: we also speak HL7v2 and FHIR. :)
Employees
8 employees in total
Company type
Established
Homepage
https://www.dia42.de
Location
Dresden

References

Interoperability and IT security in the stationary environment

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Communication
Adherence to deadlines
Quality

06/2023 - 12/2023

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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.

Project description

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.

Information Security
KHZG
Health Service
ISO/IEC 27001
Security Engineering
FHIR
Software Architectures
Cloud Integration
IT Infrastructure
Information Privacy
ISMS Spezialist ISO 27001
Information Security Management
Data Security

Workshops on quality management and software development requirements for digital medical devices

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Communication
Adherence to deadlines
Quality

02/2024 - 02/2024

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Project description

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. 

Risk Analysis
Information Security
Medical technology
ISO 13485
Medical Device Regulation
Research
ISO/IEC 27001
Artificial Intelligence
Quality Management
Software Development
Information Security Management

Digital prevention product ready for approval

Health Service

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Communication
Adherence to deadlines
Quality

01/2023 - 08/2023

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Comment

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.

Project description

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.

CE Marking
Software as a Service
Medical technology
Health Service
ISO/IEC 27001
User Experience
Information Privacy

Workshop for prospective start-ups on the reimbursement of medical devices by health insurance companies

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Communication
Adherence to deadlines
Quality

06/2024 - 06/2024

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Comment

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

Project description

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.

Medical Device Regulation
Health Service
Internationalization strategy
Start-up financing

Turnkey digital medical product incl. operation & support

Health Service

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Communication
Adherence to deadlines
Quality

01/2022 - until today

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Comment

Many thanks for the top cooperation and the very good performance.

Keep up the good work and best regards from Cologne, Ingo Buckert

Project description

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.

Information Security
Health Service
ISO/IEC 27001
Software Development
IT Services
ISO 81001-5-1
CE Marking
Software as a Service
Good Clinical Practice
ISO 62304
Medical technology
ISO 13485
Information Privacy

Project application for a research project in the field of digital medical devices

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Communication
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Quality

05/2023 - 08/2023

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Comment

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.

Project description

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 conception of a user-centred approach for requirements analysis;
  • the definition of regulatory requirements (MDR) for the utilisation of the project results as a medical device, including intended use, risk classification and documentation of the software development;
  • a concept for the development of a Marketing strategy with the involvement of relevant associations and key stakeholders;
  • A Realisation plan taking into account various possible cost units.

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 €.

Medical technology
ISO 13485
Project Coordination
Medical Device Regulation
Health Service
Research
Software Development
Market Entry Strategy
Virtual Reality

Main focus

CE Marking
Software as a Service
Medical technology
ISO 62304
ISO 13485
ISO/IEC 27001
Information Privacy
Software Development

Other skills

Information Security
Microsoft Teams
Data acquisition
Project Coordination
Medical Device Regulation
Data Management
User Experience
Research
Security Engineering
Quality Management
Software Architectures
.NET Core
IT Services
Cloud Integration
Good Clinical Practice
CSS
IT Infrastructure
Social Media
Start-up financing
ISMS Spezialist ISO 27001
.NET
Partner Management
KHZG
Health Service
Internationalization strategy
Artificial Intelligence
FHIR
Data Security Consultant
ISO 81001-5-1
Risk Analysis
HTML
C#
Business Development
Product Owner
Market Entry Strategy
Virtual Reality
Information Security Management
Data Security
+26

Industries

Health Service
0 - 10 projects
Medical technology
0 - 10 projects

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