Medical Device Clinical Research Study Audits and Quality Control
Almost all clinical investigations with medical devices require one or more reviews of documents, systems, and procedures. These are independent examinations of clinical trial data and activities (including the company’s own oversight of the clinical study activities, if applicable). The intent of these reviews is to ensure the capture, analysis, and reporting of data in accordance with the study protocol and other approved documents, and compliance with GCP, regulatory requirements and Standard Operating Procedures (SOPs).
Emergo can quality review 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)
- Medical Devices Regulation (MDR) - (study documentation only)
- Good Clinical Practices (GCP)
- ISO 14155
Medical device clinical study quality control experts
Our qualified team of medical device clinical professionals in Europe can assess compliance with all requirements outlined in the clinical study protocol, and provide corrective action recommendations as needed:
- SOPs system/ Management Reviews
- Trial Master File review/ quality control check
- Process reviews
- Investigator site inspection readiness assessments
- Assessment of protocol compliance
- Review of the adverse event reporting process
- Clinical study report reviews/ quality check
To optimize the efficacy of this process, a detailed preparation will take place including, but not limited to the scope of the review, the review methodology, and the frequency of the reviews. Support may be provided on how to address the outcome/ correct findings of these reviews to ensure quality requirements are met for your medical device study.
Please contact us for additional information on our medical device clinical research study auditing services.