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) compliance.
* Provides representation for online platforms and intermediaries under the DSA.
* Offers guidance on EU and US regulatory frameworks.
* Focuses on medical devices, diagnostics, and digital health sectors.
**Reputation / proof points**
* Established presence in the EU market for regulatory compliance.
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) compliance.
* Provides representation for online platforms and intermediaries under the DSA.
* Offers guidance on EU and US regulatory frameworks.
* Focuses on medical devices, diagnostics, and digital health sectors.
**Reputation / proof points**
* Established presence in the EU market for regulatory compliance.
Additional information
EULegalRep focuses on helping businesses understand and comply with the Digital Services Act (DSA). Their services are designed for online platforms and other digital services operating within the European Union. They aim to simplify the complex regulatory landscape, ensuring clients meet their obligations under the DSA and other relevant regulations. Engagement typically involves consultation and the establishment of necessary compliance structures.
Key Highlights
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Specializes in Digital Services Act (DSA) compliance for online platforms.
Source
“We are a regulatory and quality compliance consultancy firm based in Galway, Ireland, specializing in medical devices, diagnostics and digital health.”
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Provides representation for companies under the EU's Digital Services Act.
Source
“We are a regulatory and quality compliance consultancy firm based in Galway, Ireland, specializing in medical devices, diagnostics and digital health.”
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Covers regulatory compliance for both EU and US markets.
Source
“We help companies navigate complex EU and US regulations.”
Certifications & Trust Signals
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Firm based in Galway, Ireland, with expertise in EU regulations.
Source
“We are a regulatory and quality compliance consultancy firm based in Galway, Ireland, specializing in medical devices, diagnostics and digital health.”
Buyer Snapshot
Best for
- Online platforms and digital services needing DSA compliance.
- Companies navigating EU and US regulations.
- Medical device, diagnostic, and digital health sectors.
How engagement typically works
- Consultative approach to regulatory navigation.
- Establishing compliance frameworks.
Typical deliverables
- DSA Article 13 Representative services.
- Regulatory compliance guidance.
- EU and US regulatory navigation support.
Good to know
- Best when requiring specialized expertise in EU digital regulations.
HQ:
Galway, IE
Languages:
English, Dutch, German, French
Timezones:
Europe/Amsterdam
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
