Medical device clinical research study audits are independent examinations of clinical trial data and activities. The intent of conducting a device clinical trial audit is to ensure the capture, analysis and reporting of data in accordance with the study protocol, GCP, regulatory requirements and Standard Operating Procedures (SOPs).
Our qualified team of medical device clinical professionals in Europe, Japan, China, India or the US can perform the following auditing services to ensure compliance with all requirements outlined in the clinical study protocol:
- SOPs audits
- Master File audits
- Database audits
- Process audits
- Investigator site audits
- Clinical study report audits
We can work with you to determine what should be audited, how it will be audited, the frequency of those audits and how the clinical research study audit results will be presented for your medical device. Often, the level of auditing is guided by the importance of the trial data to regulatory authorities, risk to the study subjects, and complexity of the clinical trial.
Emergo can audit to any of the following regulations or standards:
- Medical Devices Directive (93/42/EEC and 2007/47/EC)
- Active Implantable Medical Devices Directive (90/385/EEC)
- Good Clinical Practices (GCP)
- ISO 14155-1:2003 and ISO 14155-2:2003
Please contact us for additional information on our medical device clinical research study auditing services.