Quality Management
Highest Manufacturing Standards for your Medical Device

From Concept to Series Production:
Ensuring Quality Excellence in Every Step

We are committed to guiding your project from initial concept to full-scale production with unwavering quality standards. Our manufacturing facilities meet all necessary international quality and regulatory requirements. We are certified to ISO 9001 and ISO 13485. Whether you're in the early stages of ideation or moving towards series production, we can support you with cutting-edge technology and meticulous attention to detail to guarantee your product's success.

Qualitätskontrolle bei OECHSLERhealth

Quality Management

We are committed to a quality management system, tailored at each location and certified according to ISO 9001 and EN ISO 13485 standards. We also implement and certify location-specific systems for environmental management (ISO 14001), occupational health and safety (ISO 45001), and energy management (ISO 50001), ensuring a comprehensive approach to operational excellence across all sites. Lean practices and continuous improvement are deeply embedded in our company culture, driving progress and fostering innovation throughout the organization.

Services innerhalb der Validierung bei OECHSLERhealth

Validation Services

With advanced in-house labs equipped for precision measurement, our thorough inspection protocols and repeatable quality controls enable us to maintain consistency and reliability at every step. 

  • Computed Tomography technology 
  • Various standard hand-held measuring devices
  • Profile projectors for detailed inspections
  • Comprehensive surface imaging
  • External residual dirt analyses
  • Mechanical tests including tensile and compression testing
  • Surface roughness measurements
  • Precision rolling tests

Validation is a cornerstone of our commitment to quality. Our robust validation processes ensure that every product we manufacture meets stringent regulatory standards and our customer expectations. From design to production, we continuously monitor and refine our methods to deliver precision, reliability, and excellence in every batch.

Ronja Schlueter
Quality Engineer
Ronja Schlüter als Portraitbild
Maschinenbedienung im Qualitätsbereich bei OECHSLERhealth

Technology Inside: Quality Control (QC) Lab

Our Quality Control (QC) Lab ensures precise measurement and monitoring for medical product qualification. Using a computed tomography (CT) scan with accuracy up to 4.5 micrometers, we conduct both standard and series testing. Regular calibration guarantees optimal performance. We also offer tactile and optical measurements with a multi-sensor machine, achieving 2.9 micrometer precision during production. Both systems are integrated into our CAQ system for automated data transfer, ensuring efficient and reliable quality control.

Download Our Latest QM Certificates

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Sebastian Kalmus Head of Quality Planning Sebastian Kalmus als Portraitbild

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