medcor.be

MEDCOR offers specialized consultancy services to companies in the pharmaceutical, medical device, food supplement, and cosmetic sectors across the BENELUX region. Our core areas of expertise include:

Regulatory Affairs – Focused on medicinal products and medical devices
Quality Assurance – Specializing in ISO 9001 and ISO 13485 certifications for medicinal products and medical devices
ISO 14001 certification to compete in tenders where there is more focus on ESG
Market Access – Primarily for medicinal products and medical devices
Medical Information – Covering prescription and over-the-counter medicines, medical devices, cosmetics, biocides, and food supplements
Product Claims – For medicines, medical devices, cosmetics, biocides, and food supplements

Specialized Roles

MEDCOR can also serve in key regulatory and compliance roles, including:

Responsible Person – For GDP licenses (import, purchase, warehousing & export - including customs warehouses)
Responsible Person for Information and Publicity – (N°949)
Person Responsible for Regulatory Compliance (PRRC) – In accordance with Article 15 of the MDR 2017/745
EU Authorized Representative for Medical Devices – As per Article 11 of the MDR 2017/745

Our Expertise

Our team has extensive experience in establishing Good Distribution Practice (GDP) quality systems for multinational corporations operating local commercial and sales offices within the BENELUX region. We also offer guidance on local invoicing practices to help mitigate potential tax-related challenges.

In addition, MEDCOR has a proven track record in developing and implementing ISO 9001:2015 Quality Management Systems from the ground up, particularly for medical device distributors navigating the complexities of mergers and acquisitions.

Why MEDCOR?

At MEDCOR, we are dedicated to delivering tailored consultancy services that address the specific regulatory, quality, and market access needs of our clients.

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