Vigilance

Safety monitoring in medical device studies

Patient safety and device deficiencies are monitored in clinical investigations of medical devices and in performance studies of in vitro diagnostic devices (IVD).

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.

We offer a comprehensive range of services to ensure your vigilance compliance. 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