In addition to functionality, quality is the most important asset in our highly sensitive industry. We guarantee that you can completely rely on Gsell to deliver it. Our quality management system ensures this pledge through streamlined, efficient and cost-effective processes. In that respect, we meet all the relevant regulatory requirements (e.g. ISO 13485, 21 CFR 820) and ensure that only products with guaranteed quality leave our factory.
Our quality management system is regularly inspected by customers and the various certification bodies. We see this as an opportunity to continuously improve our QA activities.
Quality is also a key aspect of our employees’ DNA. Our quality management system supports the team in everything they do. In-depth education and ongoing advanced training keep quality awareness high and expand our expertise.
Precisely inspect Quality and Reliably demonstrate Compliance
Using advanced metrology, validated inspection processes and robust quality data, we ensure the quality of your medical devices. From CMM measurements and First Article Inspections (EMPB/FAI) to Measurement System Analysis (MSA) and process capability analysis (Cp/Cpk), we provide reproducible quality evidence for safe products and stable series-production processes.
Plan Quality right from the Start
Quality begins in development. With well-designed inspection strategies, cost-effective tolerances, validation and statistical process analysis, we establish the foundation for robust quality processes at an early stage. This helps reduce development risks, streamline industrialization and safely transition medical devices into stable series-production processes.
Digitally Manage Quality Processes and Maintain Controlled Documentation
A robust Quality Management System (QMS) ensures transparency, traceability and process control. Our digital CAQ system integrates document control, audit management, CAPA, change control, risk management and training, ensuring efficient, traceable and audit-compliant quality processes.
Whether First Article Inspection, CMM measurement, Measurement System Analysis (MSA), process capability analysis (Cp/Cpk) or complex functional testing – we support you in objectively demonstrating your quality requirements and establishing stable volume production processes. Together, we create reliable quality data as the basis for clinically safe medical devices and successful audits.
