PROREGIA AG – Digitalization and Cybersecurity

We provide digitalization and cybersecurity solutions for your connected systems.

You concentrate on your core competencies. We will find the solution for you to protect your digital territory.

Our security solutions leverage on well established concepts from the financial industry (secure payment, online banking) and security agencies (encryption, counterintelligence) and go in line with usability principles.

Legal manufacturers of connected medical device systems, entering the Internet of Medical Things (IoMT), should be able to monitor and control each and every device in the market, collect and analyze data and at the same time fulfill data protection regulations of corresponding countries. Telemetry data, data channeling, security anchors, security tokens, end to end encryption and the possibility of offline use are key.

And last but not least, all according to medical device regulations, standards and guidelines (e.g. FDA 21 CFR Part 820, FDA Guidelines, EU MDR, EU IVDR, ISO 13485, IEC 62304, ISO 14971, IEC 62366, etc.)

Products and Services:
– Pre-Market Safety and Security
– PROREGIA Secure Platform – End to End Security Framework
– Post-Market Surveillance

Pre-Market Safety and Security:
Security Concept including Security Requirements, Secure Architecture, Secure Design and Implementation Principles, Safety and Security Risk Assessments

Security Validation with Mitigation Proposals and Report: Black Box and White Box Testing (e.g. Reverse Engineering, all kinds of Penetration Testing, Review of Requirements, Architectural and Detailed Design and Code Reviews)

PROREGIA Secure Platform – End to End Security Framework:
Modularly designed security frameworks for connected medical device systems (device hardware and software, sensor hardware and software, apps, cloud services, backend, pc software).

Post-Market Surveillance:
Cybersecurity Post Market Surveillance to fulfill Medical Device regulations, standards and guidelines.

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