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 companies. They focus on EU, UK, and Swiss compliance, offering services such as EU Authorized Representative (EC REP), UK Responsible Person (UKRP), and Swiss CH-REP.

**Expertise & scope**
* Acts as an EU Authorized Representative (EC REP).
* Provides UK Responsible Person (UKRP) services.
* Offers Swiss Authorized Representative (CH-REP) services.
* Specializes in EU, UK, and Swiss regulatory compliance.
* Assists with Medical Device Regulation (MDR) importer services.
* Facilitates Medical Distributor Selection & Management.
* Provides ISO Certified Translation Services.
* Offers UK Tax Relief Services.
* Consults on Quality Assurance and Regulatory Affairs (QA/RA).

**Reputation / proof points**
* ISO 13485:2016 certified for translation services.

Additional information

Shiro Business Solutions emphasizes a close working relationship with clients to ensure regulatory compliance while maintaining commercial control. They offer free, no-obligation consultations to tailor their services to specific client needs. Their expertise extends to acting as a single independent importer for the EU, UK, and Switzerland, streamlining market access for medical device companies. The firm also leverages an extensive network of global contacts to support In-Country Representative and Regulatory Importer Services.

Key Highlights

  • Acts as EU Authorized Representative (EC REP), UK Responsible Person (UKRP), and Swiss Authorized Representative (CH-REP). Source
    “We can take on the role of CH Representative, European Authorised Representative, Regulatory Importer and UK Responsible Person, making us a one-stop shop for all of your regulatory-related needs.”
  • Specializes in regulatory consulting for MedTech and Medical Device companies. Source
    “Shiro Business Solutions provides specialist advice and assistance to MedTech and Medical Device companies operating in the EU and international markets...”
  • ISO 13485:2016 certified for translation services. Source
    “We are a leading provider of translation services in Northern Europe and are ISO13485:2016 certified.”

Certifications & Trust Signals

  • Offers services as an EU MDR Importer. Source
    “EU MDR Importer”
  • Provides UK Importer and UK Responsible Person (UKRP) services. Source
    “UK Importer UK Responsible Person (UKRP)”
  • Offers Swiss Importer and Swiss Authorized Representative (CH-REP) services. Source
    “Swiss Importer Swiss Authorized Representative (CH-REP)”

Buyer Snapshot

Best for
  • MedTech and Medical Device companies seeking EU, UK, and Swiss regulatory representation.
  • Companies needing an EU Authorized Representative (EC REP) or UK Responsible Person (UKRP).
How engagement typically works
  • Collaborative approach with close client interaction.
  • Offers free initial consultations to define needs.
Typical deliverables
  • Designated EU Authorized Representative (EC REP) services.
  • Designated UK Responsible Person (UKRP) services.
  • Designated Swiss Authorized Representative (CH-REP) services.
  • Regulatory consulting and QA/RA support.
  • Distributor selection and management.
Good to know
  • Best when requiring specialized regulatory representation in the EU, UK, or Switzerland.
HQ: London, UK
Languages: English
Timezones: Europe/London
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

Additional eu_ar Details

Supports MDR
Yes
Onboarding Steps
Offers free, no-obligation consultations to determine client needs.
Supports IVDR
No
Fsca Recall Support
No
Post Market Support
No
Vigilance Contact Support
No
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