Quality Management System

MDProject can assist you in setting up a quality management system, compliant to the ISO 13485, the Canadian Medical Device Regulations (CMDR), the US QSR 21CFR820 and/or ISO 9001.

Together with your input we are able to create a lean quality system beneficial for your company, providing the tool for management coordination over your processes. The quality management system will address all required and applicable items referred to in the applicable standards and regulations.

We also can assist in preparing your company for certification against ISO 9001 and/or ISO 13485 standards, by facilitating and coordinating the management review meetings, performing and documenting supplier evaluations and executing internal audits. When needed, we can also fulfill the role of Quality manager and/or Regulatory Affairs manager.

Quality Management System/