Always compliant with Regulatory Services

Medical software must meet strict regulations. We know those regulations inside and out — and ensure your products are fully compliant.

Dawn Technology samen bouwen

Experts in both technology and regulation

Software in the healthcare sector demands the highest standards of privacy, cybersecurity, and usability. It’s no surprise that medical software is subject to complex legal requirements.

We understand these regulations in full detail — from ISO and NEN to MDR. The more complex the rules, the better we know how to navigate them.
Combining deep technical knowledge with regulatory expertise, we help you comply efficiently and sustainably through consultancy, auditing, training, and project support.

Our goal: not just compliance, but efficiency, reliability, and future readiness.

Certified under NEN 7510 and ISO 13485

Officially certified medical devices under Annex IX of the EU MDR

Proven expertise in MDR, IVDR, and GDPR

Contact Read more about our regulatory services

Fast, safe, and compliant market access

Medical software regulations are evolving quickly and are often complex. With our Regulatory Services, your product moves smoothly through certification, reducing the risk of delays or rejections. We help you maintain control, ensure data security, and operate confidently within legal boundaries — today and tomorrow.

Explore the possibilities

Our Regulatory Services

Whether it’s quality management or compliance support — our services help your organization meet the requirements for medical devices and in-vitro diagnostics (IVD).

Contact
Step 1

Regulatory consultancy

We help you set up and improve your Quality Management System (QMS) according to ISO 13485, ISO 27001, and the EU MDR. We also assist with Security Management System requirements, and provide guidance on technical documentation and Investigational Medical Device Dossiers (IMDD).
From Medical Device Software to in-vitro diagnostics, we know the rules down to the details.

[company-name]
Step 2

Auditing

Your management system must be audited internally at least once a year. We perform internal audits and assist with external audits, ensuring your systems remain compliant and evolve with your organization.

[company-name]
Step 3

Training and education

We provide customized training on MDR, ISO 13485, IEC 62304, ISO 27001, ISO 14001, and risk management — online, on-site, or in-house. Our training ensures your team stays up to date with the latest regulations and best practices.

[company-name]
Step 4

Technical and medical writing

We help build, review, and write technical documentation for medical devices — from user requirements and technical details to verification reports and clinical data.

[company-name]

The impact of our Regulatory Services

Reuma App Erasmus Dawn Technology mobile

A personal app for rheumatism patients

Nearly two million people in the Netherlands suffer from rheumatism. The disease encompasses more than a hundred chronic conditions that affect everyone differently. Together with Erasmus MC, we developed an app that is personalized for each patient.

Discover more

Wil je meer informatie over Regulatory Services?

Vul het onderstaande formulier in.

Direct contact with our experts

We believe in direct contact. That's why we'll immediately connect you with the right expert in your sector.

Awards & Recognitions

What our colleagues say

“We find it inspiring to translate complex regulations into solutions that truly work for our clients. By embedding compliance through evidence and process, we give them peace of mind and the freedom to focus on their products and users. That confidence reflects in their results — and in the market.”

Anouk van der Gracht QA/QR manager, Dawn Technology

Join our team

Want to build technology that works so seamlessly, people hardly notice it?

2 open vacancies

View our Regulatory Services vacancies
iOS Ontwikkelaar
  • On site
 Hilversum
Android Developer
  • On site
 Hilversum
What’s included in your regulatory services?
We offer consultancy, auditing, training, and technical/medical writing to help you meet compliance requirements for medical software and devices.
What certifications does Dawn Technology hold?
We’re certified under NEN 7510 and ISO 13485, and our software complies with the EU MDR, proving our commitment to security and medical software quality.
Can you help set up a Quality Management System (QMS)?
Yes. We help design, optimize, and audit QMS systems according to ISO 13485, ISO 27001, and other relevant standards.
Do you also provide webinars on medical regulations?
Absolutely. We regularly host webinars on MDR, risk management, and technical documentation. Check our events page for upcoming sessions.