Mock Audit and Training for Stage II MDSAP Assessment

The client was a Spain-based innovator in medical aesthetic technologies who was in the process of obtaining MDSAP certification to comply with Canada MDSAP requirements and MDSAP program for other regulated markets. However, the client had a proposal to transfer certain manufacturing operations to a new site and the yearly surveillance audit for ISO 13485:2016 was due in a couple of months. Additionally, the documentation review under stage I audit was concluded and on-site audit under stage II assessment was due in a month’s time. The client approached Freyr for assistance with the mock audit of their QMS systems for compliance with MDSAP requirements and for on-site training of their internal resources on QMS requirements under the MDSAP program.

How did Freyr provide support to facilitate a smooth audit and training? What were the client benefits? Read through this proven case.