Quality Management
Our services in the sector quality management systematically include the corresponding directions (93/42/EWG, 98/79/EG, QSR). Our staff members know the daily challenges in connection with quality management systems and the regulatory requirements and, due to their experience, are therefore able to advice you consequently or to support you actively during the implementation.
Our services include the following activities:
- Preparation / assistance / execution of audits
- Preparation / review of technical documentations according to the applicable guidelines for your product
- Implementation of MEDDEV–directives in your quality management system
- Consulting during the set-up of quality management systems according to ISO 13485, ISO 9001
- Consulting during change projects related to quality management systems