Quality
Certifications
BPB MEDICA™ provides painstaking service to its clientele and its primary aim is product quality. Our internal Regulatory and Quality Departments offer full-service support to our customers in the following activities:
- Quality Systems
- Vigilance
- Regulatory Affairs
- Technical documents preparation
- Regulatory and Quality support
- Formation
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.
Biopsybell is also registered with EUDAMED under SRN IT-MF-000011601, as required by MDR Regulation (EU) 2017/745.
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.
