Shiro Business Solutions (EC REP)
Shiro Business Solutions
Shiro Business Solutions offers expert regulatory consulting for MedTech and Medical Device companies. They specialize in EU, UK, and Swiss compliance, acting as EU AR, UKRP, and CH-REP.
Shiro Business Solutions is a specialized consultancy firm dedicated to assisting MedTech and Medical Device companies navigate the complex regulatory landscapes of the EU, UK, and Switzerland. They provide comprehensive support to ensure efficient market access and compliance with evolving regulations. Their services include acting as a single independent Importer, European Authorized Representative (EC REP), UK Responsible Person (UKRP), and Swiss Authorized Representative (CH-REP). They also offer Medical Distributor Selection & Management, ISO Certified Translation Services, UK Tax Relief Services, Medical Device QA/RA Outsourcing, and Design, Print & Marketing Services. With a focus on jargon-free advice, Shiro Business Solutions aims to simplify regulatory requirements for their clients, helping them maintain commercial control while expanding internationally. They leverage their extensive network and experience to provide a one-stop solution for regulatory needs.
About
**Who they are**
Shiro Business Solutions (EC REP) is a regulatory consulting firm specializing in MedTech and Medical Device compliance. They offer services as an EU Authorized Representative, UK Responsible Person, and Swiss Representative.
**Expertise & scope**
* Expertise in EU, UK, and Swiss regulatory landscapes.
* Services include acting as EU AR, UKRP, and CH-REP.
* Focus on MedTech and Medical Device companies.
**Reputation / proof points**
* Coverage extends to the EU and UK markets.
Shiro Business Solutions (EC REP) is a regulatory consulting firm specializing in MedTech and Medical Device compliance. They offer services as an EU Authorized Representative, UK Responsible Person, and Swiss Representative.
**Expertise & scope**
* Expertise in EU, UK, and Swiss regulatory landscapes.
* Services include acting as EU AR, UKRP, and CH-REP.
* Focus on MedTech and Medical Device companies.
**Reputation / proof points**
* Coverage extends to the EU and UK markets.
Additional information
Shiro Business Solutions focuses on navigating the complex regulatory requirements for medical devices in key markets. Their role as an EU Authorized Representative is crucial for manufacturers outside the EU seeking to place their devices on the European market. They also provide support for UK and Swiss compliance, ensuring a comprehensive approach for companies expanding into these regions.
Key Highlights
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Specializes in EU, UK, and Swiss regulatory compliance for MedTech and Medical Devices.
Source
“Shiro Business Solutions offers expert regulatory consulting for MedTech and Medical Device companies. They specialize in EU, UK, and Swiss compliance, acting as EU AR, UKRP, and CH-REP.”
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Provides services as an EU Authorized Representative (EU AR).
Source
“They specialize in EU, UK, and Swiss compliance, acting as EU AR, UKRP, and CH-REP.”
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Offers UK Responsible Person (UKRP) services.
Source
“They specialize in EU, UK, and Swiss compliance, acting as EU AR, UKRP, and CH-REP.”
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Provides Swiss Representative (CH-REP) services.
Source
“They specialize in EU, UK, and Swiss compliance, acting as EU AR, UKRP, and CH-REP.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers seeking EU Authorized Representation.
- Companies needing UK Responsible Person services.
- Businesses requiring Swiss Representative (CH-REP) services.
How engagement typically works
- Expert regulatory consulting.
- Specialized compliance support.
Typical deliverables
- EU Authorized Representative services.
- UK Responsible Person services.
- Swiss Representative services.
Good to know
- Best when targeting EU, UK, or Swiss markets for medical devices.
HQ:
London, UK
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU, UK
Countries:
IE, GB, DE, FR, NL
Industries:
Medical devices, IVD, Healthcare
Portfolio:
1-5, 6-25
Onboarding time:
3–21 days
Pricing model:
Per project
Starting from:
EUR 1,800
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:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
EU Entity Country:
Ireland
Can Be Named On Label:
Yes
Alternate Names:
Shiro Business Solutions
Post Market Support:
No
Vigilance Contact Support:
No
Fsca Recall Support:
No
Additional eu_ar Details
Supports MDR
Yes
Onboarding Steps
Offers free, no-obligation consultations to determine how they can effectively help clients.
Supports IVDR
No
Fsca Recall Support
No
Post Market Support
No
Vigilance Contact Support
No
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