The medical device industry is under supervision of a Notified Body and the competent authority. The regulatory requirements of the quality management system are described in the EN ISO 13485.
Valicare GmbH offers the medical device industry a broad spectrum of services.
Due to our experience in the medical device, pharmaceutical and biotechnology industry we developed a deep understanding of EN ISO 13485, GMP compliance, and pharmaceutical quality management.
This is the basis for the development and implementation of a quality management system as well as the transition to EN ISO 13485:2016. Risk management is a comprehensive part of our work within quality management. We prepare design history files, device master records, and the technical documentation of your medical devices and support you through your supplier management process. We answer questions about product qualification or process validation by risk-based concepts and hands-on support during their implementation.
It is our pleasure to consult you on your way to a GMP-compliant manufacturing of your medical devices.