Hospitals are subject to KRITIS regulations, medical technology to the MDR, the pharmaceutical sector faces pressure to comply with validation requirements, and there is a shortage of IT staff across the board. We help you to reliably meet compliance requirements whilst enabling change. Using the Microsoft platform, ISO 13485- and IEC 62304-certified development and quality processes, and software developed and documented in accordance with medical device regulations.
ISO 13485 and IEC 62304 certified
Development and documentation in accordance with the MDR
6 Microsoft Solution Areas,
14 Specialisations
Their development must be documented in accordance with MDR. Excel spreadsheets, shared drives and email threads no longer stand up to scrutiny during an audit.
You fall under the KRITIS or NIS2 regulations and need a verifiable security strategy without having to set up your own SOC.
You are developing a medical app or software that needs to be authorised as a medical device. You are looking for a partner who can handle both the technical development and the regulatory requirements.
Your equipment and laboratories use different systems. Manual documentation takes up research time that you urgently need elsewhere.
Your IT team is swamped with day-to-day tasks. Strategic issues such as cloud migration or modern work are being put on the back burner.
With the right Microsoft tools and processes, these challenges can be overcome. Here are our key services for the healthcare sector.
You are planning a medical app or software programme that must comply with regulatory requirements. We will handle the technical implementation for you: an application developed and documented in accordance with the requirements for medical devices, so that you, as the manufacturer, can place it on the market. From the initial idea through to secure operation.
Idea, design, implementation: From the initial requirements analysis through to production-ready software, as part of a documented development process.
MDR-compliant documentation: Audit-ready documentation of your software development in accordance with the requirements of the Medical Devices Regulation.
Risk classification and validation: We assist you with the classification of your software and provide the software-based foundation for regulatory approval.
Secure handling of sensitive data: Data protection-compliant storage and processing of patient and research data in the Microsoft Cloud.
We also support organisations in the healthcare sector with standard Microsoft 365 roll-outs, endpoint management and managed services.
Overview of all IT Consulting Services by novaCapta →
Are you planning an IT project in the healthcare sector? Let’s talk about the regulatory, technical and organisational requirements together.
Using a cloud-based app on Microsoft Azure, researchers can control laboratory equipment from any location, document test series and access data centrally. Cross-platform architecture reduces development costs by a third.
Using Microsoft Intune and Power Platform, we implemented a modern automation solution for the global consultancy firm specialising in the GxP-regulated sector. The solution reduces the workload on the IT department, speeds up processes and cuts costs in the long term.
Grünenthal is expanding its SharePoint platform with Nintex Workflow, thereby optimising its internal business processes. Requirements can be implemented more quickly, and workflows can be documented in a traceable manner.
Our quality management system is certified to ISO 13485, and our software development processes comply with IEC 62304. Both are the key standards for medical devices and their software.
For you, this means: we develop and operate software using processes designed for regulated environments, document everything in an audit-ready manner, and support you with classification, validation and preparation for regulatory approval. As the manufacturer, you remain responsible for placing the product on the market; we provide the software foundation for this. This combination of certified processes, in-depth Microsoft expertise and development compliant with medical device regulations is rare within the Microsoft partner ecosystem.
Through our SOC-as-a-Service offering, we provide continuous monitoring, incident response and documented security processes, tailored to the requirements of critical infrastructure. We support you throughout the NIS2 implementation process, from gap analysis through to technical implementation within the Microsoft stack.
We design Microsoft 365 and Azure environments with clear data classification, access and encryption policies. Data residency within the EU and integrated compliance tools such as Microsoft Purview form part of our standard setup for regulated sectors.
Yes. We develop medical software and apps that can be authorised as medical devices. Our development processes are certified to IEC 62304, and our quality management system to ISO 13485. We supply the software, including the documentation you need for authorisation. You remain responsible for placing the product on the market as the manufacturer.
Whether you have a specific project enquiry or are simply looking for some initial guidance – we’ll get back to you personally within 24 hours.
Mario Pufahl
CEO
