I have knowledge of this standard as in I have a Biomedical Auditor Certification. But if you asking if I have experienced it myself no. No one has except for the auditee and the auditor. The people in the manufacturing plant have procedures and requirements that the do on a regular basis. It would be surprising if they know what ISO 13485 was. So I can say I have experience with it but I have not lived it like an auditee or auditor.