Welcome at MEDCOR, I look forward to collaborating with you!

Hi there,

My name is Hendrik Staels and I am the owner and founder of MEDCOR BV. I am an industrial pharmacist by education and graduated from the university of Ghent  in 2012. 

After my graduation I started working in the life sciences industry until I started my own business in November 2018. With over 10 years of experience within regulatory affairs and quality assurance I am sure I can be of help to your organisation so don't hesitate to reach out to me using the below contact button!

Various functions held including:

- RA manager OTC Belgium & Luxembourg

- RA manager OTC Netherlands

- Involvement in price dossiers for OTC

- Responsible person WDA licenses

- Responsible for Information & Publicity

- Local vigilance person

- Guidance in MRP/DCP applications with the Netherlands as Reference Member State

- Strategic advice on regulatory topics with regards to medicines, biocides, detergents, cosmetics and food supplements

- Represent company towards Health Authority and Trade Associations

Setup and maintenance of a GDP Quality Management System. Succesful defence of the system during the initial FAMHP audit as well as consecutive surveillance audits

Regulatory Affairs support for Belgium & Luxembourg for prescription drugs

Installation of an ISO9001:2015 Quality Management System. Succesfull guidance through the certification and recertification audits performed by a certification agency associated to a notified body

Led a geographically diverse team of 5 (4 employees, 1 consultant) to ensure compliance with regulatory and EMEA Quality System requirements.

Key Responsibilities:

• Supervised EMEA QARA team, providing guidance on regulatory compliance and quality systems.
• Oversaw EMEA Quality & Environmental Management Systems (ISO standards, SOPs) and key processes like audits, document control, and management reviews.
• Led quality training, supplier management, and supported distribution centers.
• Managed vigilance reporting, CAPA/QNC processes, and field actions across EMEA.
• Conducted data analysis for system performance, reporting trends to senior management.
• Ensured compliance with Medical Device and Personal Protective Regulations.
• Provided regulatory support for sales, tenders, product launches, and CE marking requirements.
• Monitored regulatory developments, liaised with global teams, and represented the company in industry associations.
• Coordinated field safety actions and managed EUDAMED notifications in compliance with EU regulations.
• Led and participated in QARA-related projects as needed.