Every ABC device is engineered and certified to the highest European and international regulatory standards for active implantable medical devices.
Advanced Biomedical Concept operates under a certified Quality Management System. All products are developed, manufactured, and released under strict compliance with EU Medical Device Regulation (MDR 2017/745) and carry the CE mark under the supervision of a Notified Body.
Our biological matrices are manufactured under GMP conditions from carefully selected, traceable bovine pericardium. Every production batch undergoes full biocompatibility, sterility, and mechanical performance testing before release.
All ABC products are CE-marked under EU Medical Device Regulation 2017/745. Our technical documentation, clinical evaluations, and post-market surveillance plans are maintained in full compliance.
Our Quality Management System is certified to ISO 13485:2016 — the international standard for medical device quality management. Annual audits are conducted by our Notified Body.
Biological safety testing according to ISO 10993 is performed on all materials. Our pericardium-derived matrices undergo cytotoxicity, sensitisation, and implantation studies.
Production takes place in GMP-certified facilities in Italy. Full traceability from raw material selection through to finished device is maintained via our ERP system.
Across breast reconstruction, augmentation, and fat grafting
Sourced from carefully selected, traceable bovine pericardium
Published clinical data supporting product safety and efficacy
International regulatory approvals and distribution network
ABC operates a comprehensive PMS programme in accordance with MDR requirements. We systematically collect and analyse data from clinical use, literature, and vigilance sources to ensure ongoing safety and performance of our devices.
All serious incidents and field safety corrective actions are reported to competent authorities in accordance with MDR Article 87 timelines.
Post-Market Clinical Follow-up studies are conducted in partnership with clinical centres to generate long-term performance and safety data.
Our Quality team investigates all product complaints. Response targets: acknowledgement within 3 business days, resolution within 30 days for non-critical, 10 days for critical reports.
Download our quality and regulatory documentation. For IFU documents specific to each product, please visit the individual product pages.
For regulatory affairs, technical documentation requests, or notified body correspondence, please contact our Quality & Regulatory team directly.