MedicaL Devices

 BCC offers advanced services to its international clientele  covering quality and regulatory expertise within medical device industry. BCC is a recognized partner who can support you in a variety of implementation issues in product development, usability, quality management, quality assurance, qualification & validation and operations. We are specialized in regulatory standards such as EN ISO 13485, EN ISO 14971, FDA QSR 21, CRF 820, DIN EN 62366 under consideration of MDR 2017/745 or IVDR 2017/746.

Together with our network, we take over projects adapted to the current needs of our customers, but also the daily business. We develop and implement solutions adapted to the needs of our customers.

Our service represents an economic alternative to the cost-intensive in-house resources and investments. We listen to our customers, respond to their needs and define the requirements. In this way, we develop tailor-made solutions, ensure greater performance, cost-effectiveness and flexibility and thus create real added value.