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info@mdrc-services.com

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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)
CE-marking process for medical devices CE-marking process for in vitro diagnostics PRRC under MDR or IVDR Checklists >>
CE-Certificate vs. EC-Certificate Basic UDI-DI (bUDI) EUDAMED registration - a brief guide Read more >>
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Regulatory expertise dedicated to software medical devices and AI health technologies


MDRC is a specialized consultancy focused exclusively on software medical devices, AI-enabled health technologies, and digital health platforms. Our team combines regulatory and technical expertise to support market access and compliance in the EU and US.

Contact our team

The foundations of our expertise

EU and US market access We support products under MDR, IVDR, and FDA frameworks, helping companies navigate both regulatory systems End-to-end support From regulatory strategy and technical documentation to clinical evaluation, quality systems, and post-market compliance. Software medical devices We focus exclusively on software medical devices, digital health platforms, and AI-enabled healthcare technologies. Regulatory and technical expertise Our team combines regulatory, quality, clinical, cybersecurity, and software lifecycle knowledge.

Combining specialized software expertise with deep regulatory knowledge, we help companies bring innovative digital health technologies to market efficiently and compliantly.

How we work

1 Understand the product 2 Define the regulatory route 3 Build the documentation 4 Support market access From software concept to market access Regulatory, technical, clinical, quality, cybersecurity and lifecycle support

We do not start with templates. We start with the product. Our work combines regulatory strategy, technical understanding, and lifecycle documentation to create a clear route from software concept to market access.

Navigating both sides of the Atlantic

EU MDR / IVDR European market access FDA / SaMD US regulatory pathways MDRC Integrated strategy Software medical device One product, aligned regulatory routes

We support companies seeking access to both European and US markets, helping align regulatory strategies across jurisdictions and avoid unnecessary duplication of effort.

What makes us different

MDRC combined expertise Specialized focus software medical devices only Technical insight software, AI, cybersecurity Regulatory depth MDR, IVDR, FDA Focused approach tailored and direct support End-to-end support strategy to post-market

We combine technical understanding with regulatory expertise to support software medical devices throughout the entire product lifecycle.

Whether you're developing a software medical device, an AI-enabled healthcare technology, or a digital health platform, we're here to help.

Get in touch

We're ready to help you. Contact us whether you have a question about our solutions or need help with regulatory issues

Our EU office

MedDev Compliance Ltd
Souliou 1, Strovolos, 2018 Nicosia, Cyprus
Phone: +357 22253765
Email: info@mdrc-services.com
 

©2025 MDRC - Medical Devices Regulatory Compliance

Solutions

EU Authorised Representative (EC REP)

PRRC

Technical documentation

Risk management

Clinical evaluation

Notified bodies

Quality management system

Post-market surveillance system

Your products

Medical devices and medical equipment

In vitro diagnostic medical devices

Medical software

Resources

Medical Device Regulation (MDR) - basics

CE-marking process for medical devices

CE-marking process for in vitro diagnostic medical devices

UDI infographic

EUDAMED registration step by step instruction

ISO 14155:2020 structure and content

MDR-compliant technical file

Checklists

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

All checklists >>


Useful information

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

Read more >>


Cookie Policy

We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.

Send us an email:
info@mdrc-services.com

Or use the contact form below

 

Solutions

EU Authorised Representative (EC REP)

EU PRRC

Technical documentation

Risk management

Clinical evaluation

Notified Bodies

Quality management system

Post-market surveillance

Resources

Medical Device Regulation (MDR) - basics

CE-marking process for medical devices

CE-marking process for in vitro diagnostic medical devices

PRRC under MDR or IVDR

UDI infographic

EUDAMED registration step by step instruction

ISO 14155:2020 structure and content

MDR-compliant technical file

Checklists

MDR technical documentation checklist

IVDR technical documentation checklist

Technical documentation checklist for medical device software (MDSW)

MDR-compliant quality system documentation checklist

Clinical Evaluation Plan checklist

Clinical Evaluation Report checklist

All checklists >>

Articles

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

More articles >>

Devices

General medical devices and equipment

In vitro diagnostics (IVD)

Medical software

Cookie Policy

We only use essential cookies that enable core functionality and proper operation of the website. These cookies do not store any personally identifiable data. By continuing to use this website, you consent to the use of the essential cookies. You may disable these cookies by changing your browser settings, but this may affect how the website functions.
We do not use our own or third-party analytical, preferences, statistics, marketing, functional, advertisement, performance or any other non-essential cookies.