Specculo
Specculo offers specialized services through the prrc_service directory. Discover their offerings and connect for your needs.
Specculo is a provider featured in the prrc_service directory, dedicated to offering specialized solutions. This profile aims to extract the core information about Specculo to facilitate connections within the prrc_service ecosystem. While specific details regarding their headquarters, legal name, and precise service offerings are not detailed in the provided evidence, Specculo operates with English as a primary language. Further engagement with Specculo through the prrc_service directory will likely reveal more about their unique value proposition and operational scope.
About
**Who they are**
Specculo is a regulatory consulting firm specializing in representation services, regulatory affairs, and quality assurance for medical devices and IVDs in the EU and UK. Founded by Kenneth Shaw, the firm combines deep technical expertise with a hands-on, partner-driven approach.
**Expertise & scope**
* EU Authorised Representative services
* UK Responsible Person services
* Technical Documentation support
* Quality Management System (QMS) support
* PRRC (Person Responsible for Regulatory Compliance) services, acting as designated PRRC or supporting in-house PRRCs
* Market access strategy and execution
* Post-market surveillance and vigilance oversight
* Support for various device types including CAD software, implants, infusion pumps, and diagnostics
**Reputation / proof points**
* Founded out of a shared passion for helping medical device and IVD companies navigate complex regulatory compliance.
* Team of experienced consultants and subject matter experts with depth across RA/QA disciplines.
* Supports startups and established manufacturers alike, from strategic planning to operational implementation.
* Focus on ensuring quality, safety, and performance while empowering innovation.
Specculo is a regulatory consulting firm specializing in representation services, regulatory affairs, and quality assurance for medical devices and IVDs in the EU and UK. Founded by Kenneth Shaw, the firm combines deep technical expertise with a hands-on, partner-driven approach.
**Expertise & scope**
* EU Authorised Representative services
* UK Responsible Person services
* Technical Documentation support
* Quality Management System (QMS) support
* PRRC (Person Responsible for Regulatory Compliance) services, acting as designated PRRC or supporting in-house PRRCs
* Market access strategy and execution
* Post-market surveillance and vigilance oversight
* Support for various device types including CAD software, implants, infusion pumps, and diagnostics
**Reputation / proof points**
* Founded out of a shared passion for helping medical device and IVD companies navigate complex regulatory compliance.
* Team of experienced consultants and subject matter experts with depth across RA/QA disciplines.
* Supports startups and established manufacturers alike, from strategic planning to operational implementation.
* Focus on ensuring quality, safety, and performance while empowering innovation.
Additional information
Specculo offers outsourced PRRC services to help manufacturers meet their obligations under the EU MDR and IVDR. This can involve acting as the designated PRRC or providing support to an existing in-house PRRC. Their services aim to ensure ongoing compliance, accurate documentation, and effective post-market surveillance, thereby reducing regulatory risks and enhancing market confidence. They emphasize that outsourcing PRRC responsibilities alleviates the burden of hiring and training an in-house expert, allowing manufacturers to navigate the complex EU regulatory landscape more efficiently.
Key Highlights
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Offers outsourced PRRC services for EU MDR and IVDR compliance.
Source
“At Specculo, we offer outsourced PRRC services, either acting as your designated PRRC or supporting your in-house PRRC in fulfilling their obligations.”
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Specializes in representation services, regulatory affairs, and quality assurance for medical devices and IVDs in the EU and UK.
Source
“Specculo is a consulting firm specialising in representation services, regulatory affairs and quality assurance related to medical devices and IVDs in the EU and UK.”
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Provides support for a range of device types, including CAD software, implants, and diagnostics.
Source
“Computer-aided detection (CAD) software. Neuro- and cardiovascular implants and technologies. Pharmacogenomics and molecular diagnostics.”
Certifications & Trust Signals
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Founded by Kenneth Shaw, who recognized the need for a consultancy combining deep technical expertise with a hands-on, partner-driven approach.
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.”
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Supports both startups and established manufacturers in navigating regulatory compliance.
Source
“From strategic planning to operational implementation, we’ve supported startups and established manufacturers alike.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers needing EU regulatory representation.
- Companies seeking outsourced PRRC services.
- Businesses requiring QMS and regulatory affairs consulting.
How engagement typically works
- Partner-driven approach.
- Hands-on support.
- Strategic planning and operational implementation.
Typical deliverables
- Designated PRRC services.
- In-house PRRC support.
- Regulatory strategy development.
- Technical documentation review.
- QMS implementation guidance.
Good to know
- Best when requiring specialized expertise in EU and UK medical device regulations.
HQ:
Brussels, Belgium
Languages:
English, French, Dutch
Timezones:
Europe/Brussels
Status:
listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
EU, GB
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
6-25
Onboarding time:
5–21 days
Pricing model:
Retainer
Starting from:
EUR 1,800
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
Yes
Availability Hours:
Business hours
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
PRRC Qualification Summary:
Specculo offers outsourced PRRC services, acting as your designated PRRC or supporting your in-house PRRC. Their team consists of seasoned regulatory professionals with a deep understanding of EU MDR/IVDR, ensuring expert compliance with minimal risk. They help manufacturers stay audit-ready, ensuring faster approval times and lower regulatory risks. Their expertise covers PRRC role requirements & legal obligations, best practices for regulatory compliance, post-market surveillance & reporting responsibilities, and handling Notified Body & Competent Authority interactions.
Additional prrc_service Details
Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
Intake → scope & device class mapping → responsibilities matrix → workflow setup → ongoing PRRC coverage
Coverage Details
PRRC availability set to Extended hours with defined escalation path (seed summary).
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
Expertise in PRRC role requirements, legal obligations, best practices, post-market surveillance, and competent authority interactions.
Device Classes Supported
Class I, IIa, IIb, III (implied by MDR/IVDR support)
