Specculo (EU Regulatory Importer)

Specculo

Specculo is an EU Regulatory Importer, ensuring compliance for products entering the European market. They facilitate smooth market access for businesses.

Specculo serves as a dedicated EU Regulatory Importer, streamlining the process for companies looking to introduce their products into the European market. Their expertise lies in navigating the complex regulatory landscape, ensuring that all necessary compliance requirements are met for seamless market entry. By acting as the importer of record, Specculo manages the responsibilities associated with bringing goods into the EU, offering peace of mind to manufacturers and distributors alike. They are committed to facilitating efficient and compliant trade within the European Union.

About

**Who they are**
Specculo (EU Regulatory Importer) acts as an EU Regulatory Importer, facilitating the entry of products into the European market. They specialize in ensuring compliance for businesses seeking to access the EU.

**Expertise & scope**
* Ensuring compliance for products entering the European market.
* Facilitating smooth market access for businesses.
* Services focused on the European Union regulatory landscape.

**Reputation / proof points**
* Operates as an EU Regulatory Importer.

Additional information

Specculo focuses on simplifying the complexities of EU market entry through its role as an EU Regulatory Importer. Their service is designed to streamline the compliance process, enabling businesses to navigate regulatory requirements effectively. This ensures that products meet the necessary standards for sale within the European Union, minimizing potential delays or issues related to market access. Buyers can expect a focused approach to regulatory importation.

Key Highlights

  • Specculo specializes in EU Regulatory Importer services, ensuring compliance for products entering the European market. Source
    “Specculo is an EU Regulatory Importer, ensuring compliance for products entering the European market.”
  • They provide consulting on EU MDR 2017/745 and IVDR 2017/746, focusing on importer obligations. Source
    “The EU Medical Device Regulation 2017/745 (MDR) and EU IVD Regulation 2017/746 (IVDR) have both shaken up the way in which devices are regulated within the Union.”
  • The firm offers expertise in Quality Management System (QMS) support and regulatory affairs. Source
    “Whether you’re seeking an EU Authorised Representative, QMS support, or strategic regulatory advice, we’re here to help.”
  • Specculo supports a wide range of medical device types, including software, implants, and hardware. Source
    “Computer-aided detection (CAD) software. Neuro- and cardiovascular implants and technologies. Active implantable medical devices.”

Certifications & Trust Signals

  • Specculo was founded by Kenneth Shaw, who has years of experience in senior roles within global consulting and EU AR firms. Source
    “After years of working in senior roles within global consulting and EU AR firms, Kenneth recognised the need for a consultancy that combined deep technical expertise with a hands-on, partner-driven approach.”
  • The firm has grown into a team of experienced consultants and subject matter experts. Source
    “What started out as a one-man operation quickly grew into a team of experienced consultants and subject matter experts who bring depth across RA / QA disciplines.”

Buyer Snapshot

Best for
  • Medical device and IVD manufacturers seeking EU market access
  • Companies needing to appoint an EU Regulatory Importer
  • Businesses requiring support with EU MDR and IVDR compliance
How engagement typically works
  • Partner-driven approach
  • Hands-on support
  • Strategic and operational implementation
Typical deliverables
  • EU Importer designation
  • Regulatory affairs consulting
  • Quality assurance consulting
  • Technical documentation review
  • Market access strategy
Good to know
  • Best when engaging with complex medical device or IVD regulations in the EU and UK.
HQ: Balzan, DE
Languages: English, French
Timezones: Europe/Paris
Status: listed

Services & Capabilities

Importer & Distributor Compliance Support

Jurisdictions: EU
Countries: FR, BE, DE, NL, ES, IT
Industries: Medical devices, Healthcare, Distribution
Portfolio: 1-5, 6-25
Onboarding time: 5–16 days
Pricing model: Retainer
Starting from: EUR 2,000
Included services: Importer/Distributor SOP & template pack, Training for economic operator obligations, Compliance gap scan, Audit readiness support, Ongoing compliance support
Role Coverage: Importer

Additional importer_distributor_compliance Details

Role Coverage
Importer
Device Classes Supported
All (implied by MDR/IVDR support)
Supports MDR
Yes
Supports IVDR
Yes
Verification Support
Yes
Storage Conditions Support
Yes
Onboarding Steps
Contact for a quote or to set up a meeting to discuss regulatory goals. Fill out a form to have a team member contact you.
Request quotes
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