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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 compliance for medical device software in the EU and US

Supporting software medical devices, AI-driven health technologies, and digital health platforms under MDR, IVDR, and FDA frameworks.

Learn about us

Our services at a glance

FDA and EU regulatory strategy

Strategic support for MDR, IVDR, and FDA regulatory pathways for digital health technologies.

Technical documentation

Technical documentation for software medical devices and digital health technologies.

Clinical evaluation

Clinical evaluation for digital health technologies and software medical devices.

IEC 62304 and software lifecycle

Software lifecycle documentation and IEC 62304 compliance for medical software.

Cybersecurity and risk management

Cybersecurity documentation and risk management for digital health technologies.

AI   medical devices and digital health technologies

Regulatory support for AI-driven health technologies and software medical devices.

Quality management systems for software companies

QMS implementation and compliance support for software medical devices and digital health technologies.

Post-market compliance for software medical devices

Systems for monitoring safety and performance for digital health technologies and AI solutions.

Talk to a specialist

Who we help

We work with startups, growing companies, and established manufacturers developing software medical devices, AI-enabled health technologies, digital health platforms, and software-driven medical products.

360° regulatory services for software medical devices


We provide a complete range of services covering every aspect of software medical device compliance. Our services support compliance with MDR, IVDR, FDA requirements, IEC 62304, IEC 62366-1, ISO 14971, ISO 13485, and applicable cybersecurity frameworks.

Our solutions simplify your regulatory effort

With our solutions, you can save time, reduce administrative burden, and focus on what matters most – developing and delivering exceptional medical devices.

Regulatory compliance for medical device software in the EU and US

Supporting software medical devices, AI-driven health technologies, and digital health platforms under MDR, IVDR, and FDA frameworks.

Learn about us

Our services at a glance

FDA and EU regulatory strategy

Strategic support for MDR, IVDR, and FDA regulatory pathways for digital health technologies.

Technical documentation

Technical documentation for software medical devices and digital health technologies.

Clinical evaluation

Clinical evaluation for digital health technologies and software medical devices.

IEC 62304 and software lifecycle

Software lifecycle documentation and IEC 62304 compliance for medical software.

Cybersecurity and risk management

Cybersecurity documentation and risk management for digital health technologies.

AI   medical devices and digital health technologies

Regulatory support for AI-driven health technologies and software medical devices.

Quality management systems for software companies

QMS implementation and compliance support for software medical devices and digital health technologies.

Post-market compliance for software medical devices

Systems for monitoring safety and performance for digital health technologies and AI solutions.

Talk to a specialist

Who we help

We work with startups, growing companies, and established manufacturers developing software medical devices, AI-enabled health technologies, digital health platforms, and software-driven medical products.

360° services around the CE-marking


We offer a complete range of solutions that cover every aspect of the CE-marking process. From developing compliant technical documentation to serving as your authorised representative, we ensure compliance with European regulations.

Our solutions simplify your regulatory effort

With our solutions, you can save time, reduce administrative burden, and focus on what matters most – developing and delivering exceptional medical devices.

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.