Quality Management System

For certification according to DIN EN ISO 13485 and the Medical Device Regulation MDR 2017/745 (until May 2020 also MDD 93/42/EEC) it is necessary to create a Quality Management System.

Meditec Source provides reliable and customer-specific documentation to support medical device manufacturers in fulfilling regulatory requirements.

Regulations that are constantly changing require professional support. We provide individual solutions in the fields of development, procurement, manufacture and sales. We draw up all QM documentation for Certification or Re-certification through a notified body according to customer needs.

QM / Regulatory Affairs / Certification
QM / Regulatory Affairs / Certification