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 tools to navigate complex international compliance landscapes.
**Expertise & scope**
* Expertise in EU MDR and IVDR compliance.
* Offers regulatory intelligence and tools.
* Provides assistance for global market access.
* Specializes in services related to Swiss representation and EU MDR/IVDR.
**Reputation / proof points**
* Established presence in Switzerland, indicated by their contact address.
* Offers comprehensive guides for MDR and IVDR implementation.
Regulatory Globe GmbH is a Swiss-based firm specializing in regulatory affairs for medical devices. They focus on providing expert guidance and tools to navigate complex international compliance landscapes.
**Expertise & scope**
* Expertise in EU MDR and IVDR compliance.
* Offers regulatory intelligence and tools.
* Provides assistance for global market access.
* Specializes in services related to Swiss representation and EU MDR/IVDR.
**Reputation / proof points**
* Established presence in Switzerland, indicated by their contact address.
* Offers comprehensive guides for MDR and IVDR implementation.
Additional information
Regulatory Globe GmbH provides specialized support for medical device manufacturers seeking to access global markets, with a particular emphasis on EU MDR and IVDR regulations. Their services are designed to offer regulatory intelligence, practical tools, and direct assistance. Buyers can expect a focus on navigating the complexities of European medical device regulations, including specific guidance for Switzerland. The company aims to equip clients with the necessary knowledge and resources for successful market entry and ongoing compliance.
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 MDR and IVDR implementation guides.
Source
“IT INCLUDES: Complete MDR, Complete IVDR, New published EU documents, MDR / IVDR implementation guide”
Certifications & Trust Signals
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Based in Switzerland, offering local regulatory expertise.
Source
“Regulatory Globe GmbH Wilstrasse 10 6370 Oberdorf, Switzerland”
Buyer Snapshot
Best for
- Medical device manufacturers needing EU MDR/IVDR compliance support
- Companies seeking Swiss Authorized Representative services
- Businesses requiring regulatory intelligence and tools
How engagement typically works
- Consultative approach to regulatory challenges
- Provision of expert guidance and practical tools
Typical deliverables
- MDR and IVDR implementation guides
- Regulatory intelligence reports
- Assistance with global market access
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
Claim 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
Vigilance Contact Support:
Yes
Can Be Named On Label:
Yes
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, Switzerland
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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