Regulatory Globe GmbH
Regulatory Globe GmbH offers expert regulatory affairs services for medical devices, specializing in EU MDR and IVDR compliance. They provide regulatory intelligence, tools, and assistance for global market access.
Regulatory Globe GmbH is a specialized provider of regulatory affairs services for medical devices, focusing on compliance with EU MDR and IVDR regulations. They offer comprehensive support, including regulatory intelligence, implementation guides, and access to the latest EU documents. Their services are designed to help manufacturers navigate the complex landscape of medical device regulations. This includes providing tools and assistance, such as their RA Assistant 'Elly', to streamline the regulatory process. They aim to deliver global regulatory know-how directly to their clients. With a strong emphasis on the European market, Regulatory Globe GmbH assists companies in achieving and maintaining compliance, ensuring their medical devices can reach the market safely and efficiently. Their expertise covers various aspects of medical device classification and regulatory pathways.
About
**Who they are**
Regulatory Globe GmbH is a Swiss-based firm specializing in regulatory affairs for medical devices. They focus on providing expert guidance and services to help manufacturers navigate complex international regulations.
**Expertise & scope**
* Expertise in EU MDR and IVDR compliance.
* Services include regulatory intelligence, tools, and assistance for global market access.
* Offers a Regulatory Assistant tool, referred to as 'Elly'.
* Provides comprehensive guides for MDR and IVDR.
* Assistance with new EU document publications and implementation guides.
**Reputation / proof points**
* Established presence in Switzerland, indicated by their contact address in Oberdorf.
Regulatory Globe GmbH is a Swiss-based firm specializing in regulatory affairs for medical devices. They focus on providing expert guidance and services to help manufacturers navigate complex international regulations.
**Expertise & scope**
* Expertise in EU MDR and IVDR compliance.
* Services include regulatory intelligence, tools, and assistance for global market access.
* Offers a Regulatory Assistant tool, referred to as 'Elly'.
* Provides comprehensive guides for MDR and IVDR.
* Assistance with new EU document publications and implementation guides.
**Reputation / proof points**
* Established presence in Switzerland, indicated by their contact address in Oberdorf.
Additional information
Regulatory Globe GmbH provides specialized support for medical device manufacturers seeking to access the Swiss market and comply with EU regulations. Their services are designed to offer clarity and practical solutions for navigating the complexities of the EU MDR and IVDR. Buyers can expect access to regulatory intelligence and tools aimed at facilitating global market entry. The company emphasizes providing actionable guidance to ensure compliance with evolving regulatory landscapes.
Key Highlights
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Specializes in EU MDR and IVDR compliance for medical devices.
Source
“Regulatory Affairs for Medical Devices – EU MDR and IVDR”
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Offers regulatory intelligence, tools, and assistance for global market access.
Source
“Regulatory Intelligence; Tools and Services; RA Assistant”
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Provides comprehensive guides for MDR and IVDR.
Source
“IT INCLUDES: Complete MDR, Complete IVDR, New published EU documents, MDR / IVDR implementation guide”
Certifications & Trust Signals
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Established in Switzerland, providing local regulatory expertise.
Source
“Regulatory Globe GmbH Wilstrasse 10 6370 Oberdorf, Switzerland”
Buyer Snapshot
Best for
- Medical device manufacturers targeting the Swiss market.
- Companies needing assistance with EU MDR and IVDR compliance.
How engagement typically works
- Provision of regulatory intelligence and tools.
- Assistance with global market access.
Typical deliverables
- MDR and IVDR implementation guides.
- Regulatory intelligence reports.
- Access to RA Assistant tools.
Good to know
- Best when requiring specialized regulatory affairs support for medical devices.
HQ:
Oberdorf, Switzerland
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim status:
Listed
Services & Capabilities
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Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
6-25
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 1,900
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported:
Class I, IVD
Swiss Local Contact:
Yes
Swiss Entity Canton Or Region:
St. Gallen
Vigilance Contact Support:
Yes
Can Be Named On Label:
Yes
Additional ch_rep Details
Device Classes Supported
Class 1 Medical Devices
Supports MDR
Yes
Supports IVDR
Yes
Swiss Entity Canton Or Region
St. Gallen (Oberdorf)
Labeling Support
Implied through comprehensive regulatory support
Swiss Local Contact
Yes
Vigilance Contact Support
Implied through CH-REP services
Can Be Named On Label
Yes
Onboarding Steps
The website mentions MDR/IVDR implementation guides, suggesting a structured approach to onboarding.
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