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 company specializing in regulatory affairs for medical devices. They focus on providing expert guidance and tools to navigate complex international regulations.
**Expertise & scope**
* Expertise in EU MDR and IVDR compliance.
* Offers regulatory intelligence and tools.
* Provides assistance for global market access.
* Specializes in Swiss representation services.
* Develops and offers an RA Assistant tool, named Elly.
**Reputation / proof points**
* Established presence in Switzerland (CH coverage).
Regulatory Globe GmbH is a Swiss-based company specializing in regulatory affairs for medical devices. They focus on providing expert guidance and tools to navigate complex international regulations.
**Expertise & scope**
* Expertise in EU MDR and IVDR compliance.
* Offers regulatory intelligence and tools.
* Provides assistance for global market access.
* Specializes in Swiss representation services.
* Develops and offers an RA Assistant tool, named Elly.
**Reputation / proof points**
* Established presence in Switzerland (CH coverage).
Additional information
Regulatory Globe GmbH provides comprehensive support for medical device manufacturers aiming for market access in Switzerland and the EU. Their services include detailed guidance on EU MDR and IVDR, alongside tools designed to streamline regulatory processes. They offer regulatory intelligence to keep clients updated on new EU documents and implementation guides. For Swiss market entry, they provide representation services, ensuring compliance with local requirements. Their RA Assistant, Elly, is a key tool for managing regulatory affairs.
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 a Regulatory Assistant tool named Elly.
Source
“RA Assistant; Regulatory Affairs Assitant – Elly”
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Provides regulatory intelligence and tools for global market access.
Source
“Regulatory Intelligence; Tools and Services”
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Covers Swiss (CH) market representation.
Source
“Regulatory Globe GmbH Wilstrasse 10 6370 Oberdorf, Switzerland”
Certifications & Trust Signals
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Established Swiss entity providing regulatory services.
Source
“Regulatory Globe GmbH Wilstrasse 10 6370 Oberdorf, Switzerland”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EU MDR/IVDR compliance
- Companies needing Swiss Authorized Representative services
- Businesses looking for regulatory intelligence and tools
How engagement typically works
- Service-based support for regulatory affairs
- Provision of regulatory tools and intelligence
Typical deliverables
- MDR/IVDR implementation guidance
- Regulatory intelligence reports
- Swiss representation services
- RA Assistant tool (Elly)
Good to know
- Best when requiring specialized knowledge of EU MDR/IVDR and Swiss regulations.
HQ:
Oberdorf, Switzerland
Languages:
English, German, French
Timezones:
Europe/Zurich
Status:
listed
Services & Capabilities
Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
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
Additional ch_rep Details
Device Classes Supported
Class 1 Medical Devices under EU MDR
Supports MDR
Yes
Supports IVDR
Yes
Swiss Entity Canton Or Region
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.
