IQC-Group AG is a globally active independent consulting firm that advises medical device manufacturers, pharmaceutical companies, suppliers and biotechnology firms on quality and regulatory compliance. Services include validation and qualification of processes and computerized systems, audit and inspection support, and expert seminars/webinars.
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Industry:Management Consulting
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Consulting for Validation, Qualification and Compliance
Consulting on the validation and qualification of processes, software, IT infrastructures, methods and production systems, as well as on regulatory compliance requirements in medical technology and pharma.
Expert webinars and in-house training
One- and two-day expert webinars on validation, quality management, MDR, FDA inspections and GxP topics; on request also as a company-specific in-house training.
Audit and inspection support
Audit management, supplier and software audits, MDSAP preparation audits, mock audits, as well as support for FDA inspections and other regulatory assessments.
System validation and software validation
Validation of computer systems, process software, DMS, ECM, EQMS, ERP, SAP and cloud systems, as well as electronic signatures and other computer-assisted applications.
Quality management systems and ISO/GxP implementation
Implementation and optimization of quality management systems according to ISO 9001, ISO 13485 and 21 CFR Part 820, as well as support for GMP, GLP, GDP and ISO 17025.
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