Your go-to resource to address product defects, process deviations, human errors and Root Cause Analysis issues.

What We Offer

• Adequate Process to Manage Nonconformances and Corrective and Preventive Actions (CAPA)
• Documentation and Technical Writing guidance
• Training Courses on 8D Process, Investigation, and Root Cause Analysis
• Direct Support of your investigations
• Support your Quality Management System improvements

About Us

We are professionals with decades of quality assurance and manufacturing experience in ISO 9001, medical devices (ISO 13485 and 21 CFR Part 820) and pharmaceutical businesses. Our offices are located in Budapest, Hungary.

We gained experience at the world’s largest medical device and pharmaceutical companies. We have seen a lot – both good and bad practices. Our mission is to help customers to find compliant, lean, practical and effective solutions in everyday quality management.