Pieter Gibens

4 articles

Regulatory Affairs17 feb 2025 1 min

Productos sanitarios combinados: normas para la UE

Sigue estos pasos antes de lanzar productos de combinación de dispositivos médicos en la UE, incluida la aplicación del artículo 117 del MDR y la Guía de la EMA.

Quality Assurance14 oct 2021 1 min

Dendritic (DC) cells: effective sentinels for immunotherapies

Explore the crucial role of dendritic cells in DC-based immunotherapies for cancer, autoimmune diseases, and preventing graft rejection here.

14 oct 2021 7 min

Natural Killer (NK) cells: a major breakthrough in the field of ATMPs

Natural Killer (NK) cells, as part of our innate immune system, are very effective in killing different types of cells, including tumor cells. Because of these properties, they become very interesting as ATMPs for immunotherapy. Curious about the potential of Natural Killer (NK) cells and NK-cell-based immunotherapy? Learn all about them here, including the benefits and challenges.

Regulatory Affairs30 sept 2021 1 min

Medical device combination products: what regulations should you apply before marketing them in the EU?

Preparing your Medical Device Combination Products for EU Launch? Learn more on how to apply MDR Article 117 and the EMA Directive.

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