QUNIQUE GmbH

QUNIQUE GmbH

Business-Consulting-and-Services

Wohlen, Aargau
Company Tagline

Focused on solutions

Industry Category
Business-Consulting-and-Services
Company Description

QUNIQUE GmbH is a leading business consulting and services provider, focused on delivering exceptional solutions to its clients. With ISO 13485 certification, QUNIQUE specializes in providing comprehensive consulting and training services in regulatory affairs, quality management, and clinical affairs for medical devices and in-vitro diagnostic devices. QUNIQUE GmbH also serves as an authorized representative in the EU and Switzerland for medical devices, ensuring compliance and market access.

Strategically located at Bahnhofweg 17, Wohlen, Aargau 5610, CH, and with an additional office at Überseeallee 1, Hamburg, 20457, DE, QUNIQUE GmbH is ideally positioned to support its clients across Europe. The company’s expertise extends to a wide range of specialties, including quality management, regulatory affairs, authorized representation, seminars, training, and acting as a CH & EU importer. QUNIQUE GmbH excels in areas such as the Medical Device Regulation, compliance project management, remediation projects, MDSAP, IVDR, and audits.

QUNIQUE GmbH is dedicated to supporting businesses in navigating complex regulatory landscapes and achieving their strategic goals. The team continually enhances their service offerings to meet the evolving needs of the industry. We invite the manager of QUNIQUE GmbH to create a customized and exclusive company showcase and product listing on our platform, further amplifying their market presence.

Key Personnel / Employees
Valentina Shcherba Angelina Hakim Christoph Schär Schirin Weber

Compare Companies Side by Side

Compare QUNIQUE GmbH with 3 companies in Business-Consulting-and-Services

4 Companies
Comparison Field
QUNIQUE GmbH
QUNIQUE GmbH
Main Company
ELLECOM®
ELLECOM®
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The Tao of Excellence
The Tao of Excellenc...
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IMed Consultancy Ltd
IMed Consultancy Ltd
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Founded Year
2020 2015 2012
Company Size
2-10 2-10 11-50
City
Wohlen, Aargau Efringen-Kirchen, Baden-Württemberg Schaffhausen, Schaffhausen Bloxham, England
Country
Germany Switzerland
Skills & Keywords Comparing with main company
16 Total Skills
Quality Management Regulatory Affairs Medical Devices Business Consulting ISO 13485 Compliance Audits Consulting Authorized Representative Seminars/Trainings CH & EU Importer Medical Device Regulation Compliance Project Management Remediation Projects MDSAP IVDR
15 Total 1 Common 14 Unique
Match 6%
Common Skills:
Compliance
Unique Skills:
Authorized Representative Services for the EU & Switzerl(EU-Rep & CH-Rep) Clinical Affairs Clinical Evaluation for Medical Devices EU Regulation MDR Medical Device Certification +8
21 Total 21 Unique
Unique Skills:
Audit preparation Certification CH-REP Continuous Improvement Data Analysis Gap Analysis +15
19 Total 1 Common 18 Unique
Match 6%
Common Skills:
Medical Devices
Unique Skills:
21 CFR Part 820 510k Auditing CE Marking Clinical Evaluations FDA +12
4
Total Companies
2012
Oldest Founded
2
Countries
66
Unique Skills

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Alternative Company Names

This company is also known as

QUNIQUE GmbH QUNIQUE 有限责任公司 QUNIQUE जीएमबीएच