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 for global market access, particularly concerning EU MDR and IVDR compliance.
**Expertise & scope**
* Expert regulatory affairs services for medical devices.
* Specialization in EU MDR and IVDR compliance.
* Provision of regulatory intelligence, tools, and assistance.
* Support for global market access.
* Services include comprehensive MDR and IVDR guidance, updates on new EU documents, and implementation guides.
**Reputation / proof points**
* Coverage includes Switzerland (CH).
* Services are available in English, German, and French.
Regulatory Globe GmbH is a Swiss-based firm specializing in regulatory affairs for medical devices. They focus on providing expert guidance for global market access, particularly concerning EU MDR and IVDR compliance.
**Expertise & scope**
* Expert regulatory affairs services for medical devices.
* Specialization in EU MDR and IVDR compliance.
* Provision of regulatory intelligence, tools, and assistance.
* Support for global market access.
* Services include comprehensive MDR and IVDR guidance, updates on new EU documents, and implementation guides.
**Reputation / proof points**
* Coverage includes Switzerland (CH).
* Services are available in English, German, and French.
Additional information
Regulatory Globe GmbH offers a suite of tools and services designed to streamline regulatory compliance. Their offerings include a Regulatory Intelligence service, providing up-to-date information on regulations, and a Regulatory Assistant tool, which aids in managing compliance tasks. They also provide specific guides for EU MDR and IVDR, alongside resources on ISO 13485:2016 and medical device classification. The company emphasizes providing global regulatory know-how accessible through their platform.
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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Provides regulatory intelligence, tools, and assistance for global market access.
Source
“They provide regulatory intelligence, tools, and assistance for global market access.”
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Offers services in English, German, and French.
Source
“Languages: English, German, French”
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Coverage includes Switzerland (CH).
Source
“Coverage: CH”
Certifications & Trust Signals
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Regulatory Globe GmbH is established in Switzerland.
Source
“Regulatory Globe GmbH Wilstrasse 10 6370 Oberdorf, Switzerland”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EU MDR and IVDR compliance.
- Companies needing assistance with global market access for medical devices.
- Firms requiring regulatory intelligence and tools.
How engagement typically works
- Provides expert consultation and regulatory assistance.
- Offers tools and intelligence for self-service compliance management.
Typical deliverables
- Regulatory intelligence reports.
- MDR and IVDR implementation guides.
- Assistance with regulatory affairs.
- Tools for regulatory management.
Good to know
- Best when requiring specialized knowledge of EU MDR and IVDR.
- Best when seeking support for market access in Switzerland and globally.
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 I 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.
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