regulatory affairs

PendraCare has an expert Regulatory Affairs team that has successfully obtained CE and FDA approval for a wide range of medical products. It has in-depth and up to date  knowledge of the latest regulatory requirements and ensures these are implemented in PendraCare’s processes and systems.


For OEM partners PendraCare often acts as the legal manufacturer while the OEM partner distributes the products under its own brand and responsibility. In these cases PendraCare supports the OEM Regulatory Affairs teams with its filings across the world.