Quality management system optimization and workshops

Company

The client is an owner-managed family business specializing in the development, production and distribution of surgical systems for various medical disciplines. The surgical equipment and instruments are appreciated and used by surgeons and OR teams worldwide due to their above-average load testing and quality.

Competence area

• Quality Management

Project tasks

• Implementation of regulatory requirements from the company’s quality management system
• Optimization of the quality management system with regard to international compliance (FDA, ISO 13485, PMDA etc.)
• Creation of standard operating procedures (SOPs) and review with regard to regulatory requirements
• Conducting workshops for standard operating procedures (SOPs) and training the employees concerned
• Participation in optimization projects for business processes and maintenance of the QM system
• Performing internal and external audits, as well as supporting regulatory inspections and customer audits

Project duration

• 6 months

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