Management Systems

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

We can assist the maintenance and development of your QMS (see In-House Expertise) and deliver Training in Quality Systems including EN ISO 13485:2016, CFR 820 and other country GMP Requirements.

Get In Touch