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DirectoryBusiness & Technical ServicesTechnical Consulting & EngineeringKestenholzQUAREGIA GmbH
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QUAREGIA GmbH

Summary

About the company

The core activity of Quaregia GmbH is to provide services in the field of quality assurance and regulatory affairs for companies in the medical technology and pharmaceutical industries, particularly in the areas of: Regulatory Affairs, QMS implementation and support, Medical Device Software, In-Vitro Diagnostics, Combination Products, Cybersecurity, Artificial Intelligence, and Regulated Processes. The company supports customers in complying with regulatory requirements and standards, such as MDR, IVDR, FDA, and ISO 42001, and offers consulting services in these areas.

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Products & services

Industry:Technical Consulting & Engineering
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Quality & Regulatory Affairs
Regulatory affairs and quality management for medical devices, active implantables, in-vitro diagnostic devices and combination products; regulatory opinions, strategies, GMP, GAMP, GEP, GDP, GLP and auditing.
MDR/ IVDR Quality Management System Support
Support for establishing and customizing compliant QMS documentation and implementation for medical device, IVD and medical device software companies; ISO 13485, MDR, IVDR and 21 CFR Part 820.
Medical Device Software
Regulatory support for medical device software, including software safety, cybersecurity, risk management, data protection, IEC 62304 lifecycle, CSV, and submission preparation.
Computer System Validation
Validation and qualification support for computer systems and processes, including lifecycle documentation, ISO 13485, 21 CFR Part 11, GAMP4/GAMP5, PIC/S and GDPR.
Cybersecurity
Cybersecurity engineering, vulnerability analysis, secure design, risk management, testing, release support and post-market surveillance for medical devices and related systems.

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Location

Kirchbannstrasse 18
4703 Kestenholz

At a glance

Legal form
Limited Liability Company
UID
CHE-235.365.242
Founded
2019 · 7 years
Last commercial register change
August 27, 2020
Employees
1 to 10

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