Koch Consulting gives clients support in MDR
• ISO 13485, ISO 9001, ISO 17025,
• Medical Device Class I and Class IIa, sterilization of Medical Devices
• QMS and Compliance Management
• IT QMS
• Data integrity program
• Validation and Periodic review
• Internal and external audit
• Continuous improvement program
• Process optimization
• Monitoring of regulatuion and requremnt
• CTPAT (USA) or AEO (Europe)
• Performing in-house and online GMP and GDP training and coaching of the technical and academic staff.