CERTIFICATIONS

BPB MEDICA™ provides painstaking service to its clientele and its primary aim is product quality. Our internal Regulatory and Quality Departments offer a full-service support to our customers on the following activities:

Quality Systems

Regulatory Affairs

Technical documents preparation

Clinical experimentation

Vigilance 

Formation

OEM and Private Label regulatory and quality support

Our Regulatory and Quality Departments conduct rigorous tests, from the raw materials to the equipment and the finished product. This allowed the company to obtain CE, ISO 13485 and the establishment registration by FDA.

BPB MEDICA™ operates with high qualitative standards aimed at increasing customer satisfaction through a continuous improvement regime. It is a highly verticalized plant, where we start from the plastic granule and, through the various phases of the production process we arrive to the finished product.

We conduct multiple quality tests during the entire production process to reduce the production waste and grant high quality products:

Incoming controls: dimensional, visual, documental and functional.

In-process controls: either sampling plans or 100% control can be applied and the controls are visual or functional.

Finished product controls: 100% packaged product control, also on products returning from sterilization.

CERTIFIED QUALITY