ISO 14155/ GCP compliance

ISO 14155 Compliance and GCP Consulting for Medical Devices

CRO

Good Clinical Practice

The ISO 14155 addresses good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I). 

When the GCP/ISO 14155 isn't followed from the beginning of a project, this will often result in delays in approval due to improperly designed studies, missing oversights, and other failures to meet key regulatory requirements.

 

The ISO 14155 specifies general requirements intended to:

  • protect the rights, safety, and well-being of human subjects,
  • ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
  • define the responsibilities of the sponsor and principal investigator, and
  • assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

GCP Consulting Services

At the Sponsor/CRO:

  • Standard Operating Procedures (SOPs)
  • Review of Clinical investigational plan (CIP)
  • Review for adherence to SOPs and regulation
  • Quality assurance (e.g., CAPA system)

At the study site:

  • Completeness check of investigator site file (ISF)
  • Procedure for obtaining Consent Form (ICF)
  • Qualification and performance

Qserve CRO has expertise in ISO 14155 (GCP) compliance. Our clinical experts can conduct a GCP compliance check and provide corrective action recommendations for your clinical study.

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