ISO 13485 is an International Organization for Standardization (ISO) standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. EN ISO 13485:2012 has been harmonised against the EU Medical Devices Directive, so certification to this standard by an accredited certification body (Notified Body) automatically presumes compliance with specific clauses in this directive.
ConceptoMed are certified according to ISO 13485:2012.
At ConceptoMed, our entire team is dedicated to providing high quality. Our Quality Management System demonstrates our ability to provide a consistent service that meets customer requirements, all relevant regulatory requirements, quality system requirements and product requirements. Monitoring of the system enables ConceptoMed to achieve customer satisfaction, continuous improvement and prevent non-conformances.
All ConceptoMed suppliers are appropriately certified to industry standards. We are regularly subject to notified body audits.
Our operations are based on the following regulatory requirements:
93/42/EEC on Medical Devices
FDA 21CFR Part 820 Quality System regulations
Japanese Pharmaceutical and Medical Device Act (PMD Act)