Quality management

Safety comes first – that applies to all products and services from pfm medical. It is our declared aim at pfm medical to reliably meet our customers' requirements with safe products and high-quality service.

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 know and understand them. This is the only way that we can meet their requirements in terms of quality, technology and economy – in both distribution and production. Our consultants are experts in their fields, and our service is on schedule and reliable.

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.

Other ISO and CE certificates are included under the relevant pfm medical subsidiaries.

pfm medical 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® PDA)

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® PDA, Nit-Occlud® PFO, Nit-Occlud® VSD)