GCP Audit Services for Medical Devices and IVDs
Verify compliance with ISO 14155 and ISO 20916 — from sponsor processes to clinical studies.
Under the MDR and IVDR, manufacturers acting as Sponsors must ensure that all clinical activities — whether conducted internally or via a CRO — comply with Good Clinical Practice (GCP).
Our GCP audit services help you demonstrate control, compliance, and data integrity across the entire clinical function — covering both clinical investigations for medical devices and clinical performance studies for IVDs.
We audit not only individual studies, but also the systems and processes that support them, ensuring full alignment with ISO 14155, ISO 20916, and relevant MDR/IVDR and ISO 13485 requirements.
Why GCP audits matter
A GCP audit confirms that your organization’s clinical operations are robust, compliant, and inspection-ready.
It protects participant safety, ensures data reliability, and strengthens regulatory confidence.
We help you:
- Verify compliance of clinical investigations (ISO 14155) and clinical performance studies (ISO 20916)
- Assess Sponsor responsibilities, including CRO and vendor oversight
- Review SOPs and processes for study planning, monitoring, data management, and safety reporting
- Evaluate TMF/eTMF maintenance and documentation control
- Identify and mitigate compliance risks before submission or inspection
- Define and follow up on CAPAs (Corrective and Preventive Actions)
Our audit scope
Our audits address both study-specific and system-level compliance.
Study-level audits
- Pre-study, in-process, close-out, and for-cause audits
- Site, CRO, and data audits
System-level audits
- Assessment of the Sponsor’s QMS interfaces with clinical functions
- Review of SOPs, training, vendor qualification, and document management
- Oversight of CROs and service providers
- Readiness for Notified Body or Competent Authority inspections
Why Choose Us?
Experienced auditors specialized in MedTech and IVD GCP compliance
Deep understanding of ISO 14155, ISO 20916, MDR/IVDR, and ISO 13485
Balanced insight — auditors with Sponsor and CRO backgrounds
Practical, risk-based approach and clear, actionable findings
Strengthen your GCP compliance
Whether you need an audit of a specific clinical investigation or clinical performance study, or a system-level review of your Sponsor processes — we can help.
Contact us to discuss your needs or request a tailored audit proposal!