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 provider of regulatory affairs services for medical devices. They focus on simplifying 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 for the European Union market
**Reputation / proof points**
* Services are available in English and Dutch.
Groots Medical Device Expert is a specialized provider of regulatory affairs services for medical devices. They focus on simplifying 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 for the European Union market
**Reputation / proof points**
* Services are available in English and Dutch.
Additional information
Groots Medical Device Expert utilizes AI-driven automation to streamline the submission process for medical devices. Their services are designed to assist clients with navigating the complexities of regulatory pathways, including those mandated by the FDA and European authorities. Buyers can expect a focus on efficiency and expert consultation throughout the engagement.
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 types.
Source
“simplifying processes from FDA 510(k) to De Novo and PMA.”
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Provides regulatory support for the European Union market.
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 companies seeking AI-enhanced regulatory submissions
- Businesses needing support for FDA 510(k), De Novo, and PMA pathways
- Firms requiring regulatory guidance within the EU market
How engagement typically works
- Leverages intelligent automation
- Provides expert guidance
Typical deliverables
- Streamlined regulatory submission processes
- Guidance on FDA and EU regulatory requirements
Good to know
- Best when requiring specialized support for complex medical device submissions.
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
AI-powered automation and expert guidance for regulatory submissions.
Regulatory Experience
Expert guidance for medical device regulatory needs.
