Clinical Audits in Medical Device and IVD Development

A clinical audit is one of many audits we conduct regularly for our customers as it can offer strategic and operational advantages. Our auditors bring unbiased and third party insights and help uncover your blind spots or systemic issues that internal teams may overlook.  

What are Clinical Audits? 

A clinical audit is a systematic, documented evaluation designed to verify whether your clinical processes, data, and documentation meet both regulatory requirements and quality standards. For manufacturers of Medical Devices and IVDs, this means processes like clinical evaluations, clinical investigations, and post-market follow-up are audited against applicable standards, like ISO 13485, QMSR, ISO 14155 (GCP for MDs), and ISO 20916 (GCP for IVDs) and against applicable regulations (e.g. MDR 2017/745 & IVDR 2017/746 or FDA medical device clinical trial regulations).  

During the clinical audit also Data Integrity is assessed. Is clinical data accurate, traceable, and reliable, which is essential for clinical evaluations and demonstration compliance with the relevant safety and performance requirements.  

Clinical audit findings lead to corrective actions that enhance your QMS, clinical processes, and evidence generation.  

Depending on the audit scope of clinical audits typically cover: 

• Clinical investigation and trial activities 
• Post-Market Clinical Follow-up (PMCF) studies 
• Clinical Evaluation Plans and Reports (CERs) and their underlying data 
• Clinical Research Organization (CRO) oversight and management 
• Investigator site compliance 
• Clinical data management and documentation practices 
• Adherence to Good Clinical Practice (GCP) standards 
• Compliance with ISO 14155 and MDR and ISO 20916 IVDR clinical requirements 

Why clinical audits matter 

ISO 13485 mandates Internal audits as part of QMS improvement. In addition, ISO standards 14155 and 20916 expect independent audits as part of your quality management system. In practice, clinical audits are considered a fundamental requirement under standard's Good Clinical Practice (GCP) framework.  

Failing to comply with GCP exposes clinical trials (MD) and Clinical performance studies (IVD) to regulatory penalties, ethical breaches, invalid data, and significant financial and reputational damage. To avoid these risks, organizations must maintain rigorous adherence to GCP standards, robust monitoring systems, and proactive corrective processes. 

The value of expert clinical audit support 

Many medical device manufacturers lack dedicated clinical audit expertise or resources in-house, particularly small to medium-sized companies or those with limited clinical activity. Outsourcing clinical audits to specialized consultants brings several advantages: 

• Expertise: External auditors often bring deep knowledge of ISO 14155, ISO 20916, and regional GCP regulations. They bring experience from multiple sponsors and studies, offering best practices and benchmarking insights 
• Independence and Objectivity: External auditors are not involved in the day-to-day operations of your study, reducing bias. This independence strengthens credibility with regulators and ethics committees. 
• Regulatory compliance: Audits performed by recognized third parties demonstrate proactive compliance. This can reduce the risk of findings during regulatory inspections and improve trust with authorities. Their fresh perspective often uncovers systemic issues that internal teams might overlook. 

Strengthen your clinical audit program today  

Need expert support with clinical audits? Our team combines deep regulatory knowledge and hands-on experience to help you design, conduct, and respond to audits across every phase of the medical device or IVD lifecycle.  

From clinical mock audits to investigator site assessments, we ensure your clinical processes are aligned, documented, and inspection-ready.  

Don’t wait for an inspection. Be prepared. Contact us now to make compliance your competitive advantage.