All OSCOMED facilities are certified according to ISO 13485. Our processes are also based on the requirements of the GMP guidelines (21 CFR 820, FDA). For our customers, this means secure documentation, auditable processes and maximum product quality.
Reliable processes for medical technology
Quality as the basis for our actionsAt OSCOMED, quality is not a single process, but an integral part of all areas of the company. Our quality management system in accordance with ISO 13485 is consistently geared towards the requirements of medical technology and forms the basis for safe, reproducible products.
Planned and controlled business processes, continuous improvement and comprehensively trained employees ensure that legal and normative requirements are met at all times.
Quality management according to ISO 13485
Structured, monitored and traceableOur production and core processes are monitored using state-of-the-art technology and fully documented. Validated processes ensure consistent quality and a high level of process reliability throughout the entire product life cycle.
In addition to standardised procedures, we also validate customer- or product-specific processes – either internally or in collaboration with qualified external service providers. This enables us to ensure that individual requirements are implemented reliably and in compliance with standards.
Security you can rely on
Certified quality
Responsible corporate behaviour
In the interests of patients, users and the environmentOur actions are geared towards maximising customer satisfaction with high technical quality – always with the aim of ensuring patient safety and user benefits. At the same time, we are continuously developing our organisation and investing specifically in the training and further education of our employees.
When selecting resources and processes, we give equal consideration to economic and ecological aspects. Environmentally conscious behaviour is a matter of course for us, as long as it is compatible with quality requirements and the protection of patients and users. In cases of doubt, quality always takes precedence. Compliance with all relevant standards and legal requirements forms the basis of our actions.