Biostar is deeply committed to excellence and quality in all our products and services. Therefore, our facilities, manufacturing equipment and processes meet all the applicable national and international standards and we have obtained all the appropriate certificates authorising us to provide our services:
- ISO 9001: Quality Management System.
Biostar is ISO 9001-certified in response to our commitment to continuous improvement of our products and a clear focus on customer satisfaction.
- ISO 13485: Medical Devices – Quality Management System.
The certificate authorises Biostar to design, develop, manufacture, import and distribute medical devices (implants, abutments, biomaterials and instruments).
- GMP (Good Manufacturing Practices)
GMP certification demonstrates that our systems follow the Medical Device Good Manufacturing Practices set out by the FDA (21 CFR part 820).
Biostar authorisations and licences:
- AEMPS (Spanish Agency for Medicines and Medical Devices) licence
In line with Spanish Royal Decree 1591/2009, this licence authorises us to carry out the following processes:
- Manufacture of implants, abutments and instruments, and the grouping of implants, abutments and instruments.
- Importation of products, equipment and software for dental use.
- Grouping of instruments for dental surgery.
- CE marking
This provides the definitive proof that Biostar meets all the applicable regulatory requirements established for medical devices (EU Directive 93/42/EEC and Spanish Royal Decree 1591/2009).