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DirectoryBusiness & Technical ServicesManagement ConsultingOberdorf NwRegulatory Globe GmbH
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Verified· 3 sources

Regulatory Globe GmbH

Summary

About the company

The core activity of Regulatory Globe GmbH is to provide services and tools for Regulatory Affairs in the field of medical devices, particularly with regard to compliance with EU regulations such as the Medical Device Regulation (MDR) and the In-vitro-Diagnostic Regulation (IVDR). The company offers, among other things, a software called "Elly" that supports companies in meeting regulatory requirements, as well as consulting services and training.

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Regulatory Intelligence
Regulatory intelligence for medical devices and IVD: monitoring, analysis and structured communication of regulatory changes; as a general paper or company-specific coverage across multiple countries.
Regulatory Affairs Assistant (Elly)
Regulatory Affairs Assistant for medical devices and in-vitro diagnostics: up-to-date legal and guideline information, initial assessments, intended purpose development and product classification.
MDR Gap-Assessment Tool
MDR gap assessment for EU MDR compliance: gap analysis, verification of requirements, checklists for safety and performance requirements, and variants with ISO 13485 and MDD vs MDR.
IVDR Gap-Assessment Tool
IVDR gap assessment for in-vitro diagnostics: gap analysis, classification, safety and performance checklists, technical documentation, PMS/PMPF and linkage to EUDAMED.
QMSR Gap-Assessment Tool
QMSR gap assessment for the transition from QSR to QMSR: analysis of gaps in the quality management system and assessment of the relevant requirements.
Reviews

Aggregated rating

Aggregated rating
5
of 5

Aggregated from 3 reviews across all connected sources

Sources
GGoogle53
★TrustpilotSoon
PProvenExpertSoon

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Location

Wilstrasse 10
6370 Oberdorf Nw
Opening hours
Mon
09:00 - 17:00
Tue
09:00 - 17:00
Wed
09:00 - 17:00
Thu
09:00 - 17:00
Fri
09:00 - 17:00
Sat
Closed
Sun
Closed

At a glance

Legal form
Limited Liability Company
UID
CHE-420.887.314
Founded
2019 · 7 years
Last commercial register change
June 20, 2019
Employees
1 to 10

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