@ Made In Tracker - UDI EUDAMED DPP GS1

Description

Turn Regulatory Constraints into Competitive Advantage

Who are we?

Made In Tracker is the strategic partner for medical device manufacturers and regulated product companies who refuse to suffer from regulatory complexity. We combine sharp European regulatory expertise with advanced technological mastery to transform MDR/IVDR, EUDAMED, DPP, and GS1 obligations into true performance drivers.

Our DNA: a hybrid team blending seasoned regulatory consultants and data engineers, serving a clear mission — anticipate, structure, and manage your compliance before it becomes a technical problem.

Our value proposition: From regulatory chaos to operational serenity
Faced with the regulatory avalanche (UDI, EUDAMED, ESPR, GS1 traceability), you can no longer afford to manage compliance manually. Made In Tracker digitalizes and automates your regulatory processes to make them 30 times faster, while guaranteeing rigor and completeness.

The result? You enrich, structure, publish, and label your products and devices at scale, effortlessly, and transform constraints into competitive advantages.

Services

Our ecosystem of solutions for you:

EasyUDI – Centralized MDR/IVDR compliance management
Automate UDI-DI/UDI-PI generation, manage your GMDN/EMDN nomenclatures, and orchestrate your EUDAMED publications in just a few clicks.

EasyEUDAMED – Simplified registration and continuous updates
Structure and transmit your medical device data in EUDAMED in compliance with MDR/IVDR requirements, with complete version traceability.

EasyDPP – ESPR-compliant digital product passports
Create Digital Product Passports (DPP) compliant with ESPR regulation to guarantee transparency, traceability, and sustainability of your products.

EasyGS1 – Complete mastery of identification standards
Manage your GTIN, GLN, SSCC, and other GS1 identifiers in full compliance with international traceability standards.

EasyLABEL – Automated and compliant labeling
Automatically generate your regulatory labels (UDI, GS1 barcodes, legal mentions) in consistency with your product data.

EasyONBOARDING – Long-term human support
Personalized accompaniment throughout your compliance journey with dedicated experts.

Human Consulting + Technology = Performance
1) Regulatory and strategic support

MDR/IVDR, EUDAMED, ESPR, DPP compliance audits
Definition of customized regulatory roadmaps

2) Product data structuring and management
Cleaning, enrichment, and normalization of your databases
Mapping and implementation of centralized product repositories

3) Operations and large-scale deployment

Mass generation of UDI-DI, UDI-PI, BUDI, MUDI, DPP
Automated registration in EU and international databases (EUDAMED)
Creation and deployment of digital product passports (DPP)

4) Production of compliant multi-language labels

5) Integration and automation
Connection with your existing ERP, PIM, PLM systems
Automated update and publication workflows
Real-time compliance monitoring dashboards

Company's information

Year of foundation
2023  
Company size
TPE < à 10 personnes  

Nouveaux standards

QR code augmenté GS1
 
Digital Product Passport
 

Target audience

All sectors
 
DIW / building
 
Jewelry, watchmaking
 
Logistic and transport
 
Textile
 
Technical Industries
 
Cosmetics
 
E-commerce
 
Home furnishing
 
Food-service
 
Leisure
 
Fresh products
 
Healthcare
 
Mass market products
 
Wines and spirits
 

Strengths

Assets 1
Regulatory expertise + Cutting-edge technology  
Assets 2
Personalized human support  
Assets 3
Automation: 30x faster  

Target audience

Clientèle cible
 
SMEs < à 250
 
ETI < à 5000 personnes
 
GE >= à 5000 personnes
 
All sizes companies
 

GS1 certifications

GDSN product sheet
 

Activities of software publishers / integraters

ERP commercial management tool
 
Customer management tool (CRM)
 
Files management tool (GED)
 
WMS/OMS/WCS logistics management tools
 
PIM / BIM product information management
 
MES, Manufacturing Execution System
 
Image recognition
 
Blockchain solution
 
IOT solution
 

Prestations

Communication agency
 
Consumer application
 
Database
 

Manufacturers activities

Label publisher and printer
 
Printing equipment
 
Industrial marking and coding solution
 
Codebare checker
 

Consulting activities

Data management consulting
 
Strategy consulting
 
Traceability consulting
 
Management and organisation consulting
 
Supply Chain Management consulting
 
IT consulting
 

About the partner

MADE IN TRACKER

Member since 12/16/24

A propos

Tiers de confiance numérique pour LA traçabilité certifiée.

Notre Mission : Made In Tracker, par son engagement à fournir des données de la plus haute fiabilité, vise à maximiser la valeur des produits tout au long de leur cycle de vie, pour un monde plus durable.

Chez Made In Tracker, nous croyons en un monde où la transparence et l’authenticité sont les pierres angulaires de chaque transaction. Notre mission est de révolutionner la traçabilité des dispositifs médicaux, des objets, des documents, des produits, matériaux, des équipements, ... alliant technologie de pointe, conformité réglementaire officielle et respect des normes les plus strictes, pour garantir la véracité et la qualité des biens que nous consommons et chérissons.

Website link

https://madeintracker.com/

Location

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