Quality management

NICOLAY is certified to ISO 13485 for medical devices - the globally recognized standard for quality in medtech. In addition, our environmental management is certified to ISO 14001. These certifications apply uniformly to our sites in Germany and Romania - on the basis of an integrated management system.

We are MDR ready (Medical Device Regulation) and are registered with the FDA for the US market. Our processes and documentation are designed to successfully pass regulatory audits at all times.

Our quality policy pursues a competitive approach with the aim of manufacturing high-performance products. To this end, we work with clearly defined quality targets and monitor their implementation using specific key performance indicators (KPIs).

We subject all critical production processes and software solutions used to a structured validation process. Machines and systems are also qualified in accordance with the requirements of ISO 13485 before they are used in series production.

We think quality across all areas of the company - with a risk-based approach based on the requirements of ISO 14971 and ISO 13485. In this way, we safeguard not only products but also processes against deviations.

We rely on modern CAQ software to digitally support our quality assurance. We use it to record, document and analyze quality-relevant data throughout the entire product life cycle - transparently, comprehensibly and audit-proof.