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 specializing in regulatory affairs and product registration for medical devices and IVD products, with over 30 years of experience.
**Expertise & scope**
* AI-powered regulatory solutions for medical device and IVD registration.
* Streamlining compliance and accelerating market access globally.
* Services available in over 140 countries.
* Offers License holder and Authorized Representative services in more than 100 markets.
* Develops regulatory technology products: LICENSALE® and REGISLATE®.
**Reputation / proof points**
* 30 years of MedTech expertise.
* Trusted by 2500 companies.
* Facilitated over 4500 applications.
* Global presence with international offices.
Arazy Group is a consulting firm specializing in regulatory affairs and product registration for medical devices and IVD products, with over 30 years of experience.
**Expertise & scope**
* AI-powered regulatory solutions for medical device and IVD registration.
* Streamlining compliance and accelerating market access globally.
* Services available in over 140 countries.
* Offers License holder and Authorized Representative services in more than 100 markets.
* Develops regulatory technology products: LICENSALE® and REGISLATE®.
**Reputation / proof points**
* 30 years of MedTech expertise.
* Trusted by 2500 companies.
* Facilitated over 4500 applications.
* Global presence with international offices.
Additional information
Arazy Group provides comprehensive regulatory support, including European Regulatory Representative Services and Global Authorized Representative and License Holder Services. Their AI-powered platform and expert team aim to make medical devices and IVDs more accessible globally by streamlining the registration process. They emphasize separating market access activities from commercial operations, allowing companies to control their markets independently of local distributors. Their technology solutions, LICENSALE® and REGISLATE®, are designed to significantly reduce the time and cost associated with gaining and maintaining market access.
Key Highlights
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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 in multiple countries without working with various consultants.”
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Provides License holder and Authorized Representative services in more than 100 markets.
Source
“We also offer License holder and Authorized Representative services in more than 100 markets, enabling companies to separate their market access activities from commercial activities and control the markets independently from local distributors.”
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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® – Global MedTech Registration Management Software (RMS).”
Certifications & Trust Signals
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30 years of MedTech expertise.
Source
“30 Years of MedTech Expertise. Your Device Approved Faster.”
-
Trusted by 2500 companies.
Source
“2500 Companies Trust Arazy Group”
-
Facilitated over 4500 applications.
Source
“These cutting-edge solutions facilitated over 4500 MedTech product registration activities worldwide, significantly reducing the time and cost of gaining and maintaining market access.”
Buyer Snapshot
Best for
- Companies seeking to register medical devices and IVDs globally.
- Businesses needing EU Authorized Representative or License Holder services.
- Firms looking to leverage AI and technology for regulatory compliance.
How engagement typically works
- Tailored compliance solutions.
- Live demo of AI-powered platform.
- Expert guidance on market expansion.
Typical deliverables
- Medical device and IVD registration in 140+ countries.
- Authorized Representative and License Holder services.
- Regulatory technology solutions (LICENSALE®, REGISLATE®).
Good to know
- Best when seeking to streamline global market access and compliance.
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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