Medical device vigilance

Medical Device Vigilance

Qinecsa provides complete materiovigilance and post-marketing surveillance services for medical devices and combination products in line with global and local regulations, including, but not limited to:

Our experienced team delivers scalable, compliant, and robust medical device vigilance services including safety reporting and post-market surveillance services.

Sustained, Consistent, and High-Quality Delivery

Engagements are led by a team of skilled vigilance experts who understand the requirements of regulators, client challenges, and the evolving landscape.

Service Flexibility and Scale

Tailored services to meet clients’ changing needs including flexibility to respond rapidly to project demands and deviations and achieve long-term client loyalty.

Cost Effective Services

Robust infrastructure with standardized processes supported by tools to monitor workflows, to deliver class-leading efficiency for clients.

Expert Medical Device Vigilance Services

Safety management

Safety Management

Intake, processing, review, follow-up and reporting of adverse device effect (ADE) and medical device incident (MDI) in clinical and post-marketing settings

Global and local literature management

Global and Local Literature Management

AI-enabled literature screening to reduce the need for in-depth review of literature citations and abstracts by up to 50%, leveraging machine-assisted learning for enhanced precision and compliance.

Expert vigilance consultancy

Expert Vigilance Consultancy

Strategic advisory services to support post-market surveillance services including post-market surveillance plans (PMSP) and post-market clinical follow-up plans (PMCFP).

Safety and risk management

Safety and Risk Management

Generation of high quality global safety reports including periodic safety update reports (PSURs), post-market surveillance (PMS) reports, and risk management plans (RMPs) along with signal detection and management reports.