De Senex Consultancy
De Senex Consultancy
EXPERT REGULATORY COMPLIANCE SERVICES
Hands-on support for
Medical device companies
and
healthcare institutes
​
What we offer:
De Senex Consultancy
- MDR/IVDR guidance
Medical device Quality management: ISO 13485:2016,
Risk Management: ISO 14971:2019
Medical Laboratories: ISO 15189:2022
- Clinical Trial guidance
Good Clinical Practice: ICH E6(R2)
Clinical Investigation of medical devices for Human subjects: ISO 14155:2020
- Onsite 12 Hour QMS
Quality Management: ISO 9001:2015
Medical Device Quality management: ISO 13485:2016
Sustainability management: ISO 14001:2015
General Data Protection Regulations (AVG): GDPR
Welcome
to my Site
About myself
My name is Anton van den Ouden, and I am dedicated to helping start-ups and healthcare institutions navigate European regulatory compliance challenges through hands-on, onsite, and project-based consultancy
​
My Commitment to you:
- Integration of Innovation and regulatory compliance
- No nonsense documentation and no bureaucratic procedures
​
My Background:
​
4 years of experience in MDR, IVDR in academics and business.
Background in Biology and Medical Laboratory research, Msc in Business administration, Executive Master in Health Administration (health strategy and innovation) and Msc in Health Economics, Policy and Law
My unique educational background and expertise enable me to provide comprehensive support to healthcare institutions and companies in developing and implementing regulatory strategies, ensuring compliance and facilitating innovation in the medical device industry.
Let's get intouch
For any inquiries or consultation requests, please feel free to contact me via Linkedin or via the contact form below. I'm here to assist you with your regulatory needs.