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 consulting firm with 30 years of experience specializing in regulatory affairs and product registration for medical devices and IVD products. They aim to make advanced medical devices and practices accessible to patients and physicians globally.
**Expertise & scope**
* AI-powered regulatory solutions for medical device and IVD registration.
* Streamlining compliance and accelerating market access in over 140 countries.
* Offering tailored compliance solutions and regulatory expertise.
* Providing European Regulatory Representative Services.
* Global Authorized Representative and License Holder Services.
* Innovators of regulatory technology products: LICENSALE® and REGISLATE®.
**Reputation / proof points**
* 30 years of MedTech expertise.
* Trusted by 2500 companies.
* Facilitated over 4500 applications.
* Global presence in more than 100 countries, including the EU.
Arazy Group is a consulting firm with 30 years of experience specializing in regulatory affairs and product registration for medical devices and IVD products. They aim to make advanced medical devices and practices accessible to patients and physicians globally.
**Expertise & scope**
* AI-powered regulatory solutions for medical device and IVD registration.
* Streamlining compliance and accelerating market access in over 140 countries.
* Offering tailored compliance solutions and regulatory expertise.
* Providing European Regulatory Representative Services.
* Global Authorized Representative and License Holder Services.
* Innovators of regulatory technology products: LICENSALE® and REGISLATE®.
**Reputation / proof points**
* 30 years of MedTech expertise.
* Trusted by 2500 companies.
* Facilitated over 4500 applications.
* Global presence in more than 100 countries, including the EU.
Additional information
Arazy Group leverages its proprietary AI-powered platform and regulatory technology products, LICENSALE® and REGISLATE®, to streamline the complex processes of medical device and IVD registration. Their services are designed to accelerate market access across more than 140 countries. They offer specialized European Regulatory Representative Services and Global Authorized Representative and License Holder Services, enabling companies to manage market access independently from commercial activities and local distributors. This approach helps in controlling markets and separating regulatory responsibilities from sales operations.
Key Highlights
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30 years of experience in MedTech regulatory affairs and product registration.
Source
“With over 30 years of experience, our team has helped thousands of MedTech companies successfully navigate the complex registration processes”
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Offers regulatory solutions for medical device and IVD registration in over 140 countries.
Source
“We offer services available in 140+ countries worldwide, enabling companies a significant global advantage to gain market access”
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Developed regulatory technology products: LICENSALE® and REGISLATE®.
Source
“The Arazy Group is the innovator behind the most effective and widely used MedTech regulatory technology products, LICENSALE® – Global MedTech Registration System and REGISLATE®”
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Provides Global Authorized Representative and License Holder services.
Source
“Global Authorized Representative and License Holder Services”
Certifications & Trust Signals
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Trusted by 2500 companies.
Source
“2500 Companies Trust Arazy Group”
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Facilitated over 4500 applications.
Source
“These cutting-edge solutions facilitated over 4500 MedTech product registration activities worldwide”
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Global presence in more than 100 countries.
Source
“Arazy Group Consultants Inc. ... has a global presence in more than 100 countries worldwide”
Buyer Snapshot
Best for
- Companies seeking to register medical devices and IVDs globally.
- Businesses needing to streamline regulatory compliance and market access.
- Firms looking for specialized EU Authorized Representative or License Holder services.
How engagement typically works
- Consultative approach to understand client needs.
- Leveraging AI-powered technology for efficiency.
- Providing tailored solutions for unique market access requirements.
Typical deliverables
- Regulatory strategy and planning.
- Product registration support in 140+ countries.
- Authorized Representative and License Holder services.
- Access to regulatory technology platforms (LICENSALE®, REGISLATE®).
Good to know
- Best when requiring expertise in complex global medical device and IVD regulations.
HQ:
Vancouver, Canada
Languages:
English, German
Timezones:
Europe/Berlin
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
Yes
Device Classes Supported
Class I, Is, Im, Ir, IIa, IIb, III
Supports MDR
TRUE
Post Market Support
TRUE
Vigilance Contact Support
Yes
Onboarding Steps
Contact for tailored compliance solutions or a live demo of their AI-powered platform.
