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DirectoryBusiness & Technical ServicesTechnical Consulting & EngineeringZugTS Q&E GmbH
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TS Q&E GmbH

Summary

About the company

The core activity of TS Quality & Engineering is to advise and support companies in complying with regulatory requirements in the field of medical devices, particularly with regard to the MDR (Medical Device Regulation). This includes services such as MDR-GAP analyses, remediation, design control processes, clinical evaluations, and support for the approval of medical devices. The company offers its services primarily to manufacturers of medical devices and has branches in various countries, including Italy, Switzerland, the United Kingdom, and China.

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Products & services

Industry:Technical Consulting & Engineering
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7
Medical Device Design and Development
Medical device design and development with mechanical design, FEA, reverse engineering, rapid prototyping, pre-series and prototypes, plus usability and HFE support.
Quality Management and Validation
Quality system support, ISO 13485 audits, SOP drafting, MDSAP support, process validation under GAMP5, plus clean-room design and validation.
Medical Device Regulatory Consulting
Regulatory consulting for MDR, IVDR, technical documentation, design control, DHF, risk management, clinical evaluation, EUDAMED and FDA submissions.
Testing, Verification and Validation
Testing for mechanical, biological and toxicological evaluation, including material tests, test planning, standards review, statistical analysis and coordination.
Electronic Instructions for Use (eIFU)
Digital management and delivery of instructions for use with version control, QR-code access, language management, document grouping and audit trail.

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Location

Theilerstrasse 7
6300 Zug

At a glance

Legal form
Limited Liability Company
UID
CHE-285.125.875
Founded
2020 · 6 years
Last commercial register change
November 27, 2025
Employees
11 to 20

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