Vigilance, or medical device safety, must be monitored during medical device (MD) and in vitro diagnostic (IVD) medical device studies and is essential for understanding the product’s risk-benefit profile and protecting the welfare of patients and users of the device. We offer comprehensive vigilance services including medical monitoring, coding of adverse events, and safety reporting to regulatory authorities.
Patient safety and device deficiencies are monitored in clinical investigations/performance studies. We help you comply with the expectations and requirements of applicable laws and regulations. Regulatory compliance ensures an adequate level of protection for patients, users, and third parties. Together, we will find an efficient solution for implementing or optimizing your safety system.
Vigilance services may include:
- Processing of serious adverse events and device deficiencies
- Medical monitoring
- MedDRA and IMDRF coding
- Safety reporting to regulatory authorities and ethics committees
- Support during audits and inspections by authorities
- Support implementing Corrective and Preventive Actions (CAPA)
- Writing or regulatory review of the protocol (CIP/CPSP) and/or PSUR safety reports
