EULegalRep
Med-Di-Dia Limited
Med-Di-Dia is a regulatory and quality compliance consultancy firm based in Galway, Ireland, specializing in medical devices, diagnostics, and digital health. They help companies navigate complex EU and US regulations.
Med-Di-Dia, based in Galway, Ireland, is a dedicated regulatory and quality compliance consultancy firm. They specialize in supporting companies within the Medical Device, In-Vitro Diagnostics, and Digital Health sectors. Their expertise is crucial for fast-tracking innovative devices and IVDs to market, ensuring they reach healthcare services and patients efficiently. The firm offers a comprehensive suite of services designed to address the challenges posed by evolving regulations. This includes assistance with EU Market Access, US Regulatory Submissions, and assessments against new EU Medical Device/IVD regulations, including compliance with Regulation (EU) 2023/607. They also provide support for device classification, predicate device searches in the US, and US FDA Regulatory Submissions. Med-Di-Dia emphasizes the importance of expert guidance in navigating the regulatory landscape. They offer services such as clinical evaluations, advice and implementation of mandatory standards like ISO 13485:2016 for Quality Management Systems, and technical file compilation. Their goal is to help clients overcome regulatory hurdles and accelerate their progress without compromising innovation.
About
**Who they are**
EULegalRep is a regulatory and quality compliance consultancy firm based in Galway, Ireland, specializing in medical devices, diagnostics, and digital health. They assist companies in navigating complex EU and US regulations.
**Expertise & scope**
* Specializes in Digital Services Act (DSA) Article 13 Representative services.
* Provides regulatory and quality compliance consultancy.
* Focuses on medical devices, diagnostics, and digital health sectors.
* Assists with navigating EU and US regulations.
* Offers coverage across the EU.
* Supports communication in English, Dutch, German, and French.
**Reputation / proof points**
* Based in Galway, Ireland.
EULegalRep is a regulatory and quality compliance consultancy firm based in Galway, Ireland, specializing in medical devices, diagnostics, and digital health. They assist companies in navigating complex EU and US regulations.
**Expertise & scope**
* Specializes in Digital Services Act (DSA) Article 13 Representative services.
* Provides regulatory and quality compliance consultancy.
* Focuses on medical devices, diagnostics, and digital health sectors.
* Assists with navigating EU and US regulations.
* Offers coverage across the EU.
* Supports communication in English, Dutch, German, and French.
**Reputation / proof points**
* Based in Galway, Ireland.
Additional information
EULegalRep focuses on providing comprehensive support for compliance with the Digital Services Act (DSA), particularly concerning the role of an Article 13 Representative. Their services are designed for businesses operating within the EU market that need to ensure adherence to digital regulations. The firm's expertise extends to medical devices, diagnostics, and digital health, offering a specialized approach to regulatory navigation. Buyers can expect assistance with understanding and implementing the requirements mandated by EU legislation, ensuring their digital services meet compliance standards.
Key Highlights
-
Specializes in Digital Services Act (DSA) Article 13 Representative services.
Source
“We are a specialized firm that provides DSA Article 13 Representative services.”
-
Offers regulatory and quality compliance consultancy for medical devices, diagnostics, and digital health.
Source
“Med-Di-Dia is a regulatory and quality compliance consultancy firm based in Galway, Ireland, specializing in medical devices, diagnostics, and digital health.”
-
Provides assistance in navigating complex EU and US regulations.
Source
“They help companies navigate complex EU and US regulations.”
-
Supports communication in English, Dutch, German, and French.
Source
“Languages: English, Dutch, German, French”
Certifications & Trust Signals
-
Based in Galway, Ireland.
Source
“Med-Di-Dia is a regulatory and quality compliance consultancy firm based in Galway, Ireland”
Buyer Snapshot
Best for
- Companies needing a DSA Article 13 Representative.
- Businesses in the medical device, diagnostics, and digital health sectors.
- Firms navigating complex EU digital regulations.
How engagement typically works
- Consultancy-based support.
- Regulatory guidance and assistance.
Typical deliverables
- DSA Article 13 Representation services.
- Guidance on EU and US regulatory compliance.
- Support for digital health and medical device regulations.
Good to know
- Best when requiring specialized EU digital regulatory expertise.
HQ:
Galway, IE
Languages:
English, Dutch, German, French
Timezones:
Europe/Amsterdam
Claim status:
Listed
Services & Capabilities
Best DSA Legal Representative| Compare & Get Quotes
Jurisdictions:
EU
Countries:
NL
Industries:
Online platforms, Marketplaces, Hosting, SaaS
Portfolio:
1-5, 6-25
Onboarding time:
1–7 days
Pricing model:
per_market
Starting from:
EUR 300
Included services:
DSA authority contact point, Notice handling routing, Escalation workflow setup, Coordinator notification support
Notice And Action Handling:
Yes
Languages:
English
Escalation Process:
Yes
EU Entity Country:
Ireland
Notice Handling SLA:
24h
Out Of Hours Contact:
Yes
Regulator Comms Handling:
Respond with client approval
Additional dsa_art13_rep Details
Platform Size
VLOP - Very Large Online Platform
EU Entity Country
Ireland
Onboarding Steps
Onboarding involves understanding the platform's operations, identifying specific DSA obligations, and establishing the representative role. Detailed steps are likely discussed during initial consultation.
Multi Language Notices
true
