Groots Medical Device Expert
Cruxi Inc.
Cruxi offers AI-powered regulatory submission services for medical devices, simplifying processes from FDA 510(k) to De Novo and PMA. Leverage intelligent automation and expert guidance for all your regulatory needs.
Cruxi provides a comprehensive, AI-powered regulatory platform designed to streamline medical device submissions. Their services cover the entire regulatory pathway, including FDA 510(k), De Novo Classification Requests (eSTAR), Q-Submissions, PMA Supplements, and more, for both US and global markets. Utilizing intelligent automation and automated compliance checks, Cruxi aims to simplify complex regulatory processes. They offer expert guidance throughout each step, ensuring efficient and compliant submissions. The platform is built to handle diverse regulatory needs, from initial device classification to final submission packages, supporting a range of submission types and market requirements. Key services include traditional 510(k) submissions with a focus on the 90-day FDA review timeline, and support for novel, low to moderate-risk devices utilizing the eSTAR format. They also facilitate formal device classification determinations and real-time supplements with repeatable templates and checklists, making regulatory compliance more accessible and efficient for medical device manufacturers.
About
**Who they are**
Groots Medical Device Expert is a specialized service provider focused on regulatory affairs for medical devices. They aim to simplify complex regulatory submission processes.
**Expertise & scope**
* AI-powered regulatory submission services
* Support for FDA 510(k), De Novo, and PMA submissions
* Leveraging intelligent automation and expert guidance
* Regulatory support within the EU
**Reputation / proof points**
* Services available in English and Dutch
Groots Medical Device Expert is a specialized service provider focused on regulatory affairs for medical devices. They aim to simplify complex regulatory submission processes.
**Expertise & scope**
* AI-powered regulatory submission services
* Support for FDA 510(k), De Novo, and PMA submissions
* Leveraging intelligent automation and expert guidance
* Regulatory support within the EU
**Reputation / proof points**
* Services available in English and Dutch
Additional information
Groots Medical Device Expert utilizes AI-driven automation to streamline the preparation and submission of regulatory documentation. Their approach combines technological efficiency with expert human oversight, aiming to reduce the burden on medical device manufacturers navigating complex regulatory landscapes. They focus on providing clear pathways for market access within the European Union, supported by their multilingual capabilities.
Key Highlights
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Offers AI-powered regulatory submission services for medical devices.
Source
“Cruxi offers AI-powered regulatory submission services for medical devices”
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Supports FDA 510(k), De Novo, and PMA submission processes.
Source
“simplifying processes from FDA 510(k) to De Novo and PMA.”
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Provides regulatory support within the European Union.
Source
“Coverage: EU”
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Services are available in English and Dutch.
Source
“Languages: English, Dutch”
Certifications & Trust Signals
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Based in the Netherlands.
Source
“Groots Medical Device Expert”
Buyer Snapshot
Best for
- Medical device manufacturers seeking AI-enhanced regulatory submissions
- Companies needing support for FDA 510(k), De Novo, and PMA pathways
- Businesses operating within the EU market
How engagement typically works
- Leveraging automation and expert guidance
- Focus on simplifying submission processes
Typical deliverables
- Regulatory submission preparation
- AI-powered automation tools for compliance
- Expert regulatory consultation
Good to know
- Best when requiring specialized support for complex FDA and EU regulatory pathways.
HQ:
Utrecht, US
Languages:
English, Dutch
Timezones:
Europe/Amsterdam
Claim status:
Listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
EU, US, CA
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
1-5
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Starting from:
EUR 1,200
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
No
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
PRRC Qualification Summary:
Groots Medical Device Expert & Groots In Vitro Diagnostic Expert offer pragmatic CE, ISO 13485 and ISO 27001 support, from initial application to ongoing compliance. They help build a compliant Quality Management System, audit-ready documentation, and accelerate market entry. Their services are delivered with efficiency and supported by deep quality and regulatory expertise, aiming to ensure safe and effective medical devices and in-vitro diagnostic devices reach the market. They support (start-up) medical device manufacturers, distributors, importers, and authorized representatives. Trust is essential for every PRRC relationship, enabling them to protect organizations and ensure full regulatory compliance.
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 Custom with defined escalation path (seed summary).
Supports MDR
true
Supports IVDR
true
PRRC Qualification Summary
Expert guidance provided.
Regulatory Experience
Experience in FDA 510(k), De Novo, and PMA submissions.
