Medical device vigilance
- US 21 CFR Part 803
- EU MDR 2017 /745
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.
Compliant & standard processes
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
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
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
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
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.