Certifications
Standard for Medical Devices - EN ISO 13485
More than just ISO 13485 certified – tailored solutions for your requirements.
Our processes are not only certified according to ISO 13485 – we provide customized solutions precisely aligned with the regulatory requirements and individual needs of our customers. Upon request, we also ensure compliance with FDA 21 CFR Part 820 and meet the highest standards of quality and documentation. Depending on customer requirements, we implement UL or NRTL specifications and support the corresponding inspections directly at our production site. In addition, we stand for GMP-compliant development and manufacturing and provide worldwide support with product approvals.
Helping you bring compliant products to market.
Our Quality Management System (QMS) encompasses all critical quality-related processes, including supplier management, material handling, change control, documentation, CAPA, and production, to ensure consistent compliance, traceability, and risk-based decision-making.
