GPB provide unrivalled experience to support you (re-) design, prepare, implement your EN ISO 13485:2016 Quality Management Systems.
We can incorporate and embrace specific country requirements such as:
Canadian Medical Devices Conformity Assessment System (CMDCAS)
Japan MHLW Ordinance No. 169, (QMS Ordinance)
USA FDA CFR820
Brazilian Good Manufacturing (BGMP) Certification
China Good Manufacturing Practice for Medical Devices
Mexico GMP Requirements & Technovigilance