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Mitarbeiterin scannt Prüfmittel und sitzt am Schreibtisch vor dem Startbildschirm von PRIMAS validated

Validated test equipment management in medical technology - from PRIMAS online to PRIMAS validated

Since 2009, Richard Wolf GmbH has been using PRIMAS online to manage its more than 4,000 pieces of test equipment. Since regulatory requirements meanwhile demand the use of a validated test equipment management system, an uncomplicated and quick changeover to PRIMAS validated was to take place.

The products of Richard Wolf GmbH are known for their quality. It is not without reason that the company has earned its place at the forefront of endoscopic diagnosis and therapy in human and veterinary medicine over the past 100 years. Professional test equipment management is an important cornerstone for ensuring and guaranteeing product quality. The company previously used the PRIMAS online IT solution, which was individually tailored to its needs and covers the complete process of test equipment management: calibration, organization and documentation.

Due to regulatory requirements of 21 CFR part 820 and ISO 13485, it was necessary to switch to the validatable and thus audit-proof software solution from PRIMAS. Testo Industrial Services implemented this change to PRIMAS validated smoothly during operation.

Your advantage: Our competence

  • Fully comprehensive validation service: Standardized validation concept supplemented by user-specific configurations including GxP-compliant validation documentation
  • Safety: Ensuring the validated state over the entire system lifecycle of PRIMAS validated.
  • Comprehensive support: validation know-how throughout the process reorganization
  • Efficient partnership: Smooth process and low effort due to close cooperation and competent project management

More about our services

Datenlogger, Prüfmittelmanagement mit PRIMAS

Test equipment management with PRIMAS

Holistic test equipment management solution with many pragmatic modules

Kalibrierung direkt an Ihren Anlagen

On-site calibration

Mobile technicians and engineers are on duty for you throughout Germany

Unser Full-Service im Bereich Logistik

Collection and delivery service

Safe transport of your high-quality test equipment

Kalibrierung eines Sensors in einem Tauchbecken

Service portfolio

Your partner for calibration, gauge management, qualification and validation