ISS AG, Integrated Scientific Services
Consultancy for regulatory compliance, clinical evidence and quality systems for medical devices and in‑vitro diagnostics. Services include clinical evaluations and investigations, QMS implementation and remediation aligned with ISO 13485 and 21 CFR 820, global market registrations, regulatory intelligence, medical device software lifecycle support and AI/cybersecurity advisory. Headquarters in Bern, Switzerland; ISO 13485 certified.
Industries
Nr. of Employees
small (1-50)
ISS AG, Integrated Scientific Services
Products
Regulatory submission and registration management application
Database-backed application to centralise regulatory submissions and registrations with tracking, automated reporting, task management and configurable templates for country-specific re‑registrations.
Regulatory submission and registration management application
Database-backed application to centralise regulatory submissions and registrations with tracking, automated reporting, task management and configurable templates for country-specific re‑registrations.
Services
Clinical evaluations and medical writing
Preparation of clinical evaluation reports and performance evaluations for medical devices and IVDs according to applicable regulatory requirements.
Clinical operations and CRO services
End-to-end clinical project management including study design, regulatory/ethics submissions, site management, data management, statistics and publication support.
Quality management and technical documentation
QMS implementation, optimisation, remediation and technical documentation preparation aligned with ISO 13485 and other international standards.
Global registration and regulatory affairs
Coordination of international registrations, dossier compilation and interaction with local authorities for market access.
Digital solutions: software, AI and cybersecurity consulting
Support for medical device software development, AI tool integration and cybersecurity risk management to meet regulatory and development requirements.
Corporate services: due diligence, inspections and expert opinions
Scientific due diligence for M&A, support during inspections and preparation of independent expert reports for authorities and courts.
Clinical evaluations and medical writing
Preparation of clinical evaluation reports and performance evaluations for medical devices and IVDs according to applicable regulatory requirements.
Clinical operations and CRO services
End-to-end clinical project management including study design, regulatory/ethics submissions, site management, data management, statistics and publication support.
Quality management and technical documentation
QMS implementation, optimisation, remediation and technical documentation preparation aligned with ISO 13485 and other international standards.
Global registration and regulatory affairs
Coordination of international registrations, dossier compilation and interaction with local authorities for market access.
Digital solutions: software, AI and cybersecurity consulting
Support for medical device software development, AI tool integration and cybersecurity risk management to meet regulatory and development requirements.
Corporate services: due diligence, inspections and expert opinions
Scientific due diligence for M&A, support during inspections and preparation of independent expert reports for authorities and courts.
Expertise Areas
- Clinical trial management
- Clinical evaluation and IVD performance evaluation
- Quality management systems and ISO 13485 compliance
- Regulatory strategy and global registrations (MDR / IVDR)
Key Technologies
- Medical device software lifecycle engineering
- AI/ML integration for clinical and device applications
- Cybersecurity risk assessment frameworks for MedTech
- Clinical data management systems