Focused on solutions
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.
Compare QUNIQUE GmbH with 3 companies in Business-Consulting-and-Services
| Comparison Field |
QUNIQUE GmbHMain Company |
ELLECOM®View Profile |
The Tao of Excellenc...View Profile |
IMed Consultancy LtdView Profile |
|---|---|---|---|---|
|
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
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Germany | Switzerland | ||
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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
|
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