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.
**Expertise & scope**
* Expertise in EU, UK, and Swiss regulatory compliance.
* Services include acting as EU Authorized Representative (EC REP), UK Responsible Person (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.
**Expertise & scope**
* Expertise in EU, UK, and Swiss regulatory compliance.
* Services include acting as EU Authorized Representative (EC REP), UK Responsible Person (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 (EC REP) focuses on navigating the complex regulatory landscapes of the EU, UK, and Switzerland for medical device manufacturers. Their role as an EU Authorized Representative is crucial for companies seeking to place their devices on the European market, ensuring compliance with relevant directives and regulations. They also provide services for UK and Swiss market access, offering a comprehensive solution for companies with multi-regional strategies. Engagement typically involves understanding the specific device, its classification, and the manufacturer's existing compliance documentation to tailor their representation services effectively.
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 (EC REP), UK Responsible Person (UKRP), and CH-REP.
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 companies requiring EU Authorized Representative services
- Companies seeking UK Responsible Person (UKRP) services
- Manufacturers needing CH-REP services
How engagement typically works
- Consultative approach to regulatory compliance
- Focus on specific market access needs (EU, UK, CH)
Typical deliverables
- Designation as EU Authorized Representative
- Designation as UK Responsible Person
- Designation as CH-REP
Good to know
- Best when manufacturers have MedTech or Medical Devices requiring market access in the EU, UK, or Switzerland.
HQ:
London, UK
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
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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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