🔍 Competence in qualification and validation As a contract manufacturer, GEMÜ develops and produces for the medical technology sector. We provide you with comprehensive support in the areas of qualification and validation to ensure compliant product development and manufacturing. Our services in this area include ✅ Regulatory review of contract documents ✅ Ensuring that all regulatory requirements are met in the development and manufacture of products ✅ Support with qualification and validation during the project phases ✅ Regulatory review of project documents prior to series release ✅ Evaluation and documentation of production-relevant changes ✅ Accompaniment of external audits ✅ Active participation in professional associations and standardization committees Our goal: to supply high-quality products that are regulatory compliant thanks to sound qualification and validation processes. Are you looking for competent support in the area of qualification and validation in regulated markets? We will be happy to assist you. #GEMÜ #RegulatoryAffairs #Validation #GMP #Compliance
GEMÜ Medical’s Post
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Excellent focus on qualification and validation 👏 two pillars that ensure both patient safety and compliance in MedTech manufacturing. Great to see GEMÜ’s strong commitment to regulatory excellence and collaboration across the industry.