Arazy Group
Arazy Group Consultants Inc.
Arazy Group offers AI-powered regulatory solutions for medical device and IVD registration in over 140 countries. With 30 years of expertise, they streamline compliance and accelerate market access globally.
Arazy Group is a leading consulting firm specializing in regulatory affairs and product registration for medical devices and IVD products. Leveraging 30 years of experience and an AI-powered platform, they help companies navigate complex global compliance requirements, fast-tracking device registrations in over 140 countries. Their cutting-edge technology provides instant access to customized submission files, automated compliance workflows, and real-time process management, significantly reducing the time and cost of gaining and maintaining market access. Arazy Group offers solutions like LICENSALE® and REGISLATE®, alongside European Regulatory Representative Services and Global Authorized Representative and License Holder Services. With a global presence and 12 international offices, Arazy Group provides tailored solutions to meet unique client needs, from early-stage start-ups to top multinational corporations. Their mission is to make life-saving medical devices available to patients and physicians worldwide by simplifying the regulatory journey and accelerating market access.
About
**Who they are**
Arazy Group is a provider of regulatory solutions for medical device and IVD registration, leveraging AI to streamline compliance processes. With a significant history in the field, they aim to accelerate global market access for their clients.
**Expertise & scope**
* AI-powered regulatory solutions
* Medical device and IVD registration
* Global market access in over 140 countries
* Expertise in EU, UK, and CH regulatory landscapes
**Reputation / proof points**
* 30 years of expertise in regulatory compliance
Arazy Group is a provider of regulatory solutions for medical device and IVD registration, leveraging AI to streamline compliance processes. With a significant history in the field, they aim to accelerate global market access for their clients.
**Expertise & scope**
* AI-powered regulatory solutions
* Medical device and IVD registration
* Global market access in over 140 countries
* Expertise in EU, UK, and CH regulatory landscapes
**Reputation / proof points**
* 30 years of expertise in regulatory compliance
Additional information
Arazy Group focuses on simplifying the complex regulatory pathways for medical devices and in vitro diagnostics. Their approach utilizes AI to manage the registration process across a wide range of international markets. Buyers should consider their extensive global coverage, which includes the EU, UK, and Switzerland, as a key benefit for companies seeking to expand their product reach. The company's long-standing experience suggests a deep understanding of the nuances involved in international medical device compliance.
Key Highlights
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Offers AI-powered regulatory solutions for medical device and IVD registration.
Source
“Arazy Group offers AI-powered regulatory solutions for medical device and IVD registration”
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Supports market access in over 140 countries.
Source
“registration in over 140 countries”
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Possesses 30 years of expertise in regulatory compliance.
Source
“With 30 years of expertise, they streamline compliance”
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Provides coverage for EU, UK, and CH markets.
Source
“Coverage: EU, UK, CH”
Certifications & Trust Signals
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30 years of expertise in regulatory compliance.
Source
“With 30 years of expertise, they streamline compliance”
Buyer Snapshot
Best for
- Companies seeking AI-driven regulatory solutions for medical devices and IVDs.
- Businesses aiming for rapid market access in over 140 countries.
- Manufacturers needing support for EU, UK, and CH regulatory compliance.
How engagement typically works
- Leverages AI for streamlined compliance.
- Focuses on accelerating global market access.
Typical deliverables
- Regulatory solutions for medical device registration.
- Regulatory solutions for IVD registration.
- Assistance with market access in 140+ countries.
Good to know
- Best when a provider with extensive international coverage and AI-driven efficiency is required.
HQ:
Vancouver, Canada
Languages:
English, German
Timezones:
Europe/Berlin
Claim status:
Listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU, UK, CH
Countries:
DE, IE, GB
Industries:
Medical devices, IVD, Healthcare
Portfolio:
6-25, 26-100
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
EUR 4,000
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
IVD
Post Market Support:
Yes
Labeling Review:
No
EU Entity Country:
Germany
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
No
Additional eu_ar Details
Supports IVDR
true
Device Classes Supported
Class I, Is, Im, Ir, IIa, IIb, III
Supports MDR
true
Post Market Support
Implied through 'gain and maintain market access in multiple countries throughout the product life cycle'.
Vigilance Contact Support
Implied through 'European Regulatory Representative Services' and 'Global Authorized Representative' services.
Onboarding Steps
The website mentions tailored solutions and working closely with clients to understand their specific requirements, implying a customized onboarding process.
EU Entity Country
Not explicitly stated, but coverage includes EU.
Fsca Recall Support
Not explicitly stated.
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