Quality management
Safety comes first – that applies to all products and services from pfmmedical. It is our declared aim at pfmmedical to reliably meet our customers' requirements with safe products and high-quality service.
We manage our quality
We work with a flexible and certified quality management system. Compliant with legal requirements and in line with the company’s strategies, we take guidance from the following principles.
Focus on customers
We maintain personal contact with our customers because we want to understand them. This is the only way we can fulfil the regulatory, qualitative, technical and economic requirements - in sales and production. Our advice is expert and our service is reliable and punctual.
Standardised processes
We safeguard our quality through standardised processes in development, manufacture and distribution. This ensures a consistently high standard throughout.
Proven safety
It is more important to avoid faults and errors beforehand than to rectify them afterwards. In order to satisfy the highest demands, we monitor the quality and safety of our products and services on a regular basis.
Certificates
You will find all our certificates in the Downloadcenter.
Worldwide authorization
pfmmedical products are registered in Europe (with the CE mark) and are also authorized in all the relevant markets around the world such as USA, Canada, China, Japan and Australia.
Examples of authorization by the American Food and Drug Administration (FDA):
- Implantable port systems (Jet Port®, T-Port)
- Peripherally inserted central venous catheters (PICC)
- Surgical mesh implants (TiMesh)
- Cardio vascular implants (Nit-Occlud® PDAThe ductus arteriosus connects the aorta with the pulmonary artery. While this connection ensures the blood circulation in the unborn, it usually closes shortly after birth…)
Example of authorization in Japan by the national Pharmaceuticals and Medical Devices Agency (PMDA):
- Surgical mesh implants (TiLENE®)
Examples of authorization in Canada by Canada Health, the national health authority:
- Implantable port systems (Jet Port®)
- Peripherally inserted central venous catheters (PICC)
- Surgical mesh implants (TiMesh)
- Cardio vascular implants (Nit-Occlud® PDAThe ductus arteriosus connects the aorta with the pulmonary artery. While this connection ensures the blood circulation in the unborn, it usually closes shortly after birth…, Nit-Occlud® PFOThe foramen ovale is an oval opening in the wall separating the left and right upper chambers of the heart. In the unborn child the cardiac septum is not closed completely…, Nit-Occlud® VSDVentricular septal defect refers to a hole in the wall separating the two lower chambers (ventricles) of the heart…)