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

EMEA senior QARA manager:

In this role I've led a team of 5 people in different geographies (4 employees and 1 consultant).

Tasks included but were not limited to:

• Manage and supervising of EMEA QARA teammates in order to provide guidance and support in maintaining the compliance of regulatory and EMEA Quality System requirements.
• Oversee the EMEA Quality & Environmental Management Systems, maintain compliance with the quality system requirements, applicable internal controls and corporate polices, i.e., SOPs, ISO,– including but not limited to the following processes:
  • Quality System / Environmental Management System: Management Review, Internal Audits, Document and Records Control, Quality System planning.
  • Training: Coordinate/lead Quality system related training sessions for cross-functional team attendance.
  • Supplier Management: Assure right level of controls and management of suppliers having impact on QS.
  • Distribution: Assure support and control to EMEA Distribution center(s).
  • Vigilance Reporting: Assure on-time reporting of vigilance reports and follow-up with EMEA Competent Authorities and Notified Bodies.
  • CAPA/QNC: Assure compliance with regulatory requirements; as well as reporting to upper manager any major or critical nonconformance resulted from internal/external audits and performance of management systems.
  • Field Action: Assure timely and efficient execution of field actions in EMEA.

• Perform data analysis to monitor quality / environmental systems performance and compliance, ensure monthly trend is provided to upper management as scheduled. Responsible for providing feedback to Global process owners for continuous improvement.
• Monitors compliance to the Medical Device Regulation and Personal Protective Regulation.
• Sales / Tender Support
  • Provide necessary Regulatory information on products to support tenders.
  • Support product market introduction.
  • Ensures EMEA requirements (e.g. CE marking, product registration requirements) are considered and met before product launch and the necessary documentation is available.
  • Approve promotional materials.
• Internal SME on EMEA Regulations:
  • Monitor new and emerging regulatory developments, work with the US team to create the vision of future direction, and proactively support the EMEA products business strategies to ensure any notification requirements are met.
  • Provide representation at Industry associations and Standard committees within the EMEA.
• Distribution Activities
  • Co-ordinate Field Safety Corrective Actions in close co-operation with QA.
  • Notify the HPRA (Irish CA) of O&M Halyard Inc distribution activities and of all products placed on the EU market which classification does not require a Notified Body intervention.
  • Work on EUDAMED
  • Notify relevant Competent Authorities of the placing of the products on the market as per country specific regulations.
  • Communicate with the Notified Body and competent authorities as required.
• Manage and participate in QARA related projects, as required.