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.
Experts in technology regulation
Software in the healthcare sector demands the highest standards of privacy, cybersecurity, and usability. So it’s no surprise that medical software is subject to complex legal requirements, such as the EU’s Medical Device Regulation (MDR)
Our team of experts can help you navigate the regulatory maze, helping you bring Software as a Medical Device or Software in a Medical Device, to market quickly, safely, and compliantly.
Combining deep technical knowledge with regulatory expertise, we help you comply efficiently and sustainably through consultancy, auditing, training, and project support.
Our goal? Your product’s efficiency, reliability, and future-readiness through smart and efficient regulatory compliance
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
Fast, safe, and compliant market access
Regulations for medical devices are complex and constantly evolving. Our Regulatory Services help your product move smoothly through certification, reducing the risk of delays or rejections. We help you maintain control, ensure data security, and operate confidently within legal boundaries both now and in the future.
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).
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.
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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.
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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.
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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.
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The impact of our Regulatory Services
Een persoonlijke app voor reumapatiënten
Bijna twee miljoen Nederlanders hebben last van reuma. De ziekte omvat meer dan honderd chronische aandoeningen en is dus voor iedereen anders. Samen met het Erasmus MC ontwikkelden we een app die voor elke patiënt persoonlijk is.
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.
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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.
Anouk van der Gracht
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
0 open vacancies
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.