Arazy Group
Arazy Group Consultants Inc.
Arazy Group is a leading regulatory affairs consulting firm specializing in medical device and IVD product registration. They offer AI-powered solutions and expert guidance to accelerate market access in over 140 countries.
Arazy Group is a premier consulting firm with over 30 years of experience, dedicated to streamlining regulatory affairs and product registration for medical devices and IVDs. Their mission is to facilitate the global availability of innovative medical technologies. Leveraging cutting-edge AI-powered technology and deep regulatory expertise, Arazy Group provides solutions that expedite device registration in over 140 countries. Their platform offers customized submission files, automated compliance workflows, and real-time process management, significantly reducing time-to-market and associated risks. They offer comprehensive services including global authorized representative and license holder services, ensuring compliance and market access across diverse regions. Arazy Group's commitment to client success is demonstrated through personalized support and a focus on building long-term partnerships, making them a trusted advisor for companies ranging from startups to multinational corporations.
About
**Who they are**
Arazy Group is a regulatory affairs consulting firm that specializes in the registration of medical devices and In Vitro Diagnostic (IVD) products. They leverage AI-powered solutions and expert guidance to facilitate market access.
**Expertise & scope**
* Specializes in medical device and IVD product registration.
* Offers AI-powered solutions for regulatory affairs.
* Provides expert guidance to accelerate market access.
* Supports market access in over 140 countries.
* Focuses on Swiss regulatory representation.
**Reputation / proof points**
* Coverage includes Switzerland (CH).
Arazy Group is a regulatory affairs consulting firm that specializes in the registration of medical devices and In Vitro Diagnostic (IVD) products. They leverage AI-powered solutions and expert guidance to facilitate market access.
**Expertise & scope**
* Specializes in medical device and IVD product registration.
* Offers AI-powered solutions for regulatory affairs.
* Provides expert guidance to accelerate market access.
* Supports market access in over 140 countries.
* Focuses on Swiss regulatory representation.
**Reputation / proof points**
* Coverage includes Switzerland (CH).
Additional information
When engaging Arazy Group for Swiss Authorized Representative services, buyers can expect a focus on efficient market access for medical devices and IVDs. Their approach integrates AI-driven tools with seasoned regulatory expertise, aiming to streamline the registration process across numerous global markets. The firm's specialization in over 140 countries suggests a broad understanding of diverse regulatory landscapes. For Swiss representation, they provide local contact and support, ensuring compliance with national requirements.
Key Highlights
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30 years of MedTech regulatory experience.
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 140+ countries worldwide.
Source
“We offer services available in 140+ countries worldwide, enabling companies a significant global advantage”
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Provides License holder and Authorized Representative services in over 100 markets.
Source
“We also offer License holder and Authorized Representative services in more than 100 markets”
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Innovators of LICENSALE® and REGISLATE® regulatory technology.
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
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking Swiss representation.
- Companies aiming to accelerate market access globally.
- Firms looking for AI-enhanced regulatory consulting.
How engagement typically works
- Expert guidance and consultation.
- AI-powered solution integration.
- Focus on efficient registration processes.
Typical deliverables
- Swiss Authorized Representative services.
- Regulatory affairs consulting.
- Market access strategy support.
Good to know
- Best when requiring specialized support for medical device and IVD product registration in Switzerland and globally.
HQ:
Vancouver, Canada
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:
26-100
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
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, Class IIa, Class IIb, Class III
Swiss Local Contact:
Yes
Can Be Named On Label:
Yes
Labeling Support:
Yes
Vigilance Contact Support:
Yes
Additional ch_rep Details
Included Services Detailed
Initial portfolio intake and mandate setup for Swiss representation, Operational workflow for Swissmedic queries and manufacturer responses, Support for labeling text placement adjacent to the CH-REP symbol and address details, Coordination of vigilance reporting and field safety corrective actions
Excluded Services
Notified Body certification services, Legal representation in disputes, Distributor commercial management
Onboarding Steps
Onboarding involves understanding client's specific requirements to provide tailored solutions for market access.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
Class I, IIa, IIb, III (Medical Devices); Same as EU IVD (IVD Devices)
Supports MDR
Implied through EU classification alignment
Supports IVDR
Implied through EU classification alignment
Labeling Support
Implied through offering services in Switzerland
Swiss Local Contact
Implied through offering services in Switzerland
Vigilance Contact Support
Implied through Authorized Representative services
Can Be Named On Label
Implied through Authorized Representative services
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