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 leading consulting firm with over 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.
* Services available in over 140 countries worldwide.
* Offers License holder and Authorized Representative services in more than 100 markets.
* Streamlines compliance and accelerates market access.
* Provides tailored solutions to meet unique client needs throughout the product lifecycle.
* Develops and utilizes proprietary regulatory technology products: LICENSALE® (Global MedTech Registration System) and REGISLATE® (Global MedTech Registration Management Software).
**Reputation / proof points**
* 30 years of MedTech expertise.
* Trusted by 2500 companies.
* Facilitated over 4500 applications worldwide.
* Global presence with international offices.
Arazy Group is a leading consulting firm with over 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.
* Services available in over 140 countries worldwide.
* Offers License holder and Authorized Representative services in more than 100 markets.
* Streamlines compliance and accelerates market access.
* Provides tailored solutions to meet unique client needs throughout the product lifecycle.
* Develops and utilizes proprietary regulatory technology products: LICENSALE® (Global MedTech Registration System) and REGISLATE® (Global MedTech Registration Management Software).
**Reputation / proof points**
* 30 years of MedTech expertise.
* Trusted by 2500 companies.
* Facilitated over 4500 applications worldwide.
* Global presence with international offices.
Additional information
Arazy Group's proprietary technology platforms, LICENSALE® and REGISLATE®, are designed to significantly reduce the time and cost associated with gaining and maintaining market access for MedTech products. These solutions are utilized by thousands of regulatory affairs professionals. The company emphasizes a collaborative approach, working closely with clients to understand specific requirements and deliver effective, efficient solutions for global market entry and ongoing compliance.
Key Highlights
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30 years of MedTech regulatory expertise.
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 services in over 140 countries worldwide.
Source
“We offer services available in 140+ countries worldwide, enabling companies a significant global advantage”
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Developed proprietary regulatory technology: 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® – Global MedTech Registration Management Software”
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Facilitated over 4500 MedTech product registration activities.
Source
“These cutting-edge solutions facilitated over 4500 MedTech product registration activities worldwide”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies seeking to streamline medical device and IVD registration globally.
- Businesses needing to establish an EU Authorized Representative or License Holder.
- Manufacturers looking to accelerate market access in over 140 countries.
How engagement typically works
- Collaborative, working closely with clients to understand unique needs.
- Leveraging proprietary AI-powered technology and expert guidance.
Typical deliverables
- Regulatory strategy and consultation.
- Product registration and market access services.
- Authorized Representative and License Holder services.
- Access to proprietary regulatory technology platforms.
Good to know
- Best when clients require support across multiple international markets.
- Best when clients can benefit from technology-driven compliance solutions.
HQ:
Vancouver, Canada
Languages:
English, German
Timezones:
Europe/Berlin
Claim status:
Listed
Services & Capabilities
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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 contacting them for tailored solutions or a demo, and that they work closely with clients to understand specific requirements, implying a consultative onboarding process.
EU Entity Country
Not explicitly stated, but coverage includes EU.
Fsca Recall Support
Not explicitly stated.
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