Pharmacovigilance Services for Medical Devices
At OC Vigilance, we understand the importance of ensuring the safety and efficacy of medical devices used by patients and consumers. Our team of pharmacovigilance and regulatory experts provides specialized services designed to ensure regulatory compliance and maintain a positive safety profile for medical devices. At OC Vigilance, we focus on delivering individualized and effective solutions for efficient lifecycle management of medical devices.
We seek to improve health and safety by reporting, recording and assessing adverse incidents, taking action and reporting them in accordance with current legislation and MEDDEV guidelines.
Our services include
- Implementation and Maintenance of Medical Device Vigilance Systems
We assist in implementing vigilance systems for clients who do not have one in place, as well as drafting various standard operating procedures. We also support the updating and/or review of these documents.
- Post-Marke Surveillance
We conduct continuous monitoring of medical devices and prepare post-market surveillance plans and their associated reports (Periodic Safety Reports and Post-Market Surveillance Reports). - Clinical Evaluation
At OC Vigilance, we help our clients prepare clinical evaluation report plans, along with post-market clinical follow-up plans and their corresponding periodic reports, all supervised by clinical experts. - Adverse Incident Management
We have standardized processes for receiving, evaluating, and reporting adverse incidents, ensuring compliance with current international and national regulations. - Medical Device Surveillance Consulting
We offer a personalized consulting service in medical device surveillance, helping our clients to address any questions or challenges they may encounter in their daily activities, including scientific advice in responding to Notified Body requirements. We provide an approach tailored to their specific resources and needs, ensuring strict compliance with current regulations at all times. - Medical Device Surveillance System Audits
We conduct internal and external audits, ensuring a risk-based approach to verify that surveillance system processes are carried out efficiently, identifying areas for improvement and optimization. - Medical Device Surveillance Training
We offer training and educational programs tailored to our clients to ensure a complete understanding of medical device surveillance requirements and how to implement them effectively.