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DirectoryBusiness & Technical ServicesResearch & DevelopmentBernISS AG, Integrated Scientific Services
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ISS AG, Integrated Scientific Services

Summary

About the company

The core activity of ISS AG (Integrated Scientific Services) is to advise and support companies in the medical technology and medical device industry in the development, approval and market launch of medical devices. This includes in particular: Quality management and ISO 13485 certification, Technical documentation and creation of device descriptions, Clinical project management, including document management, data management and statistics, Regulatory Affairs and support in the approval of medical devices, Cybersecurity consulting and development of medical device software, Strategy and consulting services for clinical trials and market access. The company supports its customers in complying with regulatory requirements and standards to ensure that their medical devices meet the requirements of the authorities and can be successfully placed on the market.

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Products & services

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Technical Consulting & Engineering
Software Development
✓ Offered12
Global Registrations
Global registration of medical devices and IVDs, including strategy for new markets, document preparation, dossier compilation, submission, and coordination with local authorities.
Quality Management
Implementation, audit, and remediation of QMS processes for medical devices and IVDs, aligned with regulatory requirements and standards such as ISO 13485 and 21 CFR 820.
Technical Documentation
Creation, updating, and remediation of technical documentation for market access for medical devices and IVDs, including compliance support.
Clinical Operational Services
Planning, conduct, and oversight of clinical trials for medical devices and performance studies for IVDs, including project management, data management, statistics, and site management.
Medical Writing
Preparation of clinical evaluations and performance evaluations for medical devices and IVDs, including scoping, data collection, data assessment, and regulatorily compliant documentation.
Reviews

Aggregated rating

Aggregated rating
4.9
of 5

Aggregated from 8 reviews across all connected sources

Sources
GGoogle4.98
★TrustpilotSoon
PProvenExpertSoon

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Location

Nordring 4a
3013 Bern

At a glance

Legal form
Corporation
UID
CHE-110.109.001
Founded
2003 · 23 years
Last commercial register change
May 16, 2025
Employees
1 to 10

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