Our Intention ...

Failure avoidance and cost reduction through efficient CAPA management

When exporting medical technology products to the USA, the requirements of the FDA (Food & Drug Aministration) must be met. One of their requirements is the use of an effective Corrective Action / Preventive Action system (CAPA).

Approximately 30% of the contested discrepencies resulting from FDA inspections can be attributed to poor implementation of CAPA systems, or to the absence of such systems.

Risk management is an indispensable part of entrepreneurial management in any business.

Use the systematic FMEA approach to analyze systems and risks in order to avoid needless costs and liabilities.

Project Management in compliance with APQP as an active element across all phases of the product life cycle.

Learn about the benefits that the use of APQP (Advanced Product Quality Planning) will bring to your product development and planning processes.

View Complaints as an opportunity and use them as such.

Together with you we would like to explore the broader issues of the often unpleasant topic of complaints

Properly manage the complaints process and the costs associated with guaranties and warranties.