Sectors

Where our technologies are used

Our products and services are primarily aimed at highly regulated sectors such as medical technology, pharmaceuticals, trustees, law firms, doctors and public and quasi-public organisations.

30+ Years of experience

40% R&D investment ratio

100% Reliability

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Specialised services for the medical technology sector

Regulatory Affairs & MDR Consultancy

We handle all regulatory tasks for your medical device, from the technical documentation and the risk management dossier through to the clinical evaluation.
Product registration (swissdamed / EUDAMED)

We will register your company and your products with swissdamed and EUDAMED in good time, before the requirement comes into force. This will help you avoid delays and compliance breaches before they even arise.
CH-REP / EU Authorised Representative Services

Through our own EU representative office in Vienna, we ensure market access for you – whether you are a CH-REP, a Swiss importer, an authorised representative in the EU or an EU importer – in both the EU and Switzerland.
Establishment of a QMS in accordance with ISO 13485

We will set up an audit-proof, ISO 13485-compliant quality management system for you that will stand up to any audit.
Digitised, validated documentation processes

With our validated and auditable IT platform, you can digitise all your medical device documentation and replace manual, error-prone processes.
Vigilance Reporting / Post-market surveillance

We handle your vigilance reporting and post-market surveillance in accordance with Swiss and EU regulations, ensuring that no reportable incident slips through the net.
Recruitment of Regulatory Affairs Specialists

Drawing on our team and our network, we can provide you with experienced regulatory affairs and quality management specialists exactly when you need them.

Regulatory Affairs & MDR Consultancy

We handle all regulatory tasks for your medical device, from the technical documentation and the risk management dossier through to the clinical evaluation.
Product registration (swissdamed / EUDAMED)

We will register your company and your products with swissdamed and EUDAMED in good time, before the requirement comes into force. This will help you avoid delays and compliance breaches before they even arise.
CH-REP / EU Authorised Representative Services

Through our own EU representative office in Vienna, we ensure market access for you – whether you are a CH-REP, a Swiss importer, an authorised representative in the EU or an EU importer – in both the EU and Switzerland.
Establishment of a QMS in accordance with ISO 13485

We will set up an audit-proof, ISO 13485-compliant quality management system for you that will stand up to any audit.
Digitised, validated documentation processes

With our validated and auditable IT platform, you can digitise all your medical device documentation and replace manual, error-prone processes.
Vigilance Reporting / Post-market surveillance

We handle your vigilance reporting and post-market surveillance in accordance with Swiss and EU regulations, ensuring that no reportable incident slips through the net.
Recruitment of Regulatory Affairs Specialists

Drawing on our team and our network, we can provide you with experienced regulatory affairs and quality management specialists exactly when you need them.

Other sectors

Public Administration & Government Bodies	We digitise administrative processes, support tendering and the awarding of ICT contracts, and provide a robust IT infrastructure in Switzerland using open-source solutions. Ideal for maintaining full control over sensitive public sector data. All our projects are implemented in accordance with HERMES 2022, and our staff are also certified to HERMES 2022.
Research & Development	We provide support in the commercialisation of promising research projects.
Law firms, trustees, doctors	We provide secure email and application environments that are independent of third countries and support you in implementing new IT projects.