IQC-Group AG, Zurich

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.

Data integrity and documentation consulting

Analysis and assessment of processed data, compliance plans, and measures for data integrity of processes and systems, including Good Documentation Practice.

Qualification of facilities and infrastructure

Qualification of equipment, machinery, cleanrooms, utilities supply and IT infrastructures, as well as support for equipment qualification and release of facilities.

Process validation and method validation

Validation of processes, bonding processes, analytical methods, design methods and test methods, as well as statistical methods and test equipment capability.

MDR and UDI consulting

Consulting on implementation of the EU Medical Device Regulation and the Medical Device Regulation, as well as on Unique Device Identification, EUDAMED and FDA requirements.

Post-market surveillance and periodic review

Support for PMS post-market surveillance and periodic review for medical devices and regulated processes.

IQC-Group AG

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IQC-Group AG

About the company

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