Competitive advantages for medical device vendors through qualification and validation in line with ISO 13485 and GMP
Differentiate your business from the competition in creating added values for your customer relationship. Sell an additional benefit through the qualification of plants/equipment and the validation of software and control systems.
IQC assists you in the development of standardized validation packages for your systems, the construction of GMP-compliant quality management systems and the preparation of the certification. Plant Equipment Qualification
• Risk Analysis
• Installation Qualification
• Operationn Qualifizierungen
• Alignment with ISO 13485:2003 or GMP Standards
• Procedure Management industry-wide acknowledged in respect of FDA Audits in leading
• Medical Device Businesses
Software Validation
• Risk Analysis
• Installation Qualification
• Operation Qualification
• Scaled Depth of Requirements for ISO and GMP
• Automation and Control Systems within the Qualification Procedure with integrated
• Software System Validation
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