Medical Device Vigilance
- US 21 CFR Part 803
- EU MDR 2017 /745
Compliant Vigilance for Medical Device Management
Effective vigilance for medical devices is crucial not only for regulatory compliance but also for patient safety and product reputation. Our comprehensive services are designed to support manufacturers throughout the entire post-market surveillance process.
At Qinecsa, our experts are here to cover all aspects of medical device surveillance from initial incident identification to final reporting. We provide structured systems to capture, evaluate, and respond to complaints and incidents, ensuring that potential safety issues are identified and addressed promptly.
Regulatory Compliance Support
The regulatory landscape for medical device vigilance continues to evolve, with increasingly stringent requirements across global markets. Our regulatory specialists keep up-to-date with current knowledge of vigilance requirements in the UK, EU, US, and other international jurisdictions, helping your organisation stay compliant with all applicable regulations.
With consistent, cost-effective services, we provide customised strategies that ensure your products meet the specific regulatory obligations in each market while maintaining operational efficiency. Our approach includes developing robust procedures, implementing effective documentation systems, and establishing clear decision-making frameworks.
Incident Investigation and Analysis
When incidents occur, thorough investigation is essential to understand root causes and implement appropriate corrective actions. Our experienced team reviews available data using established methodologies to identify underlying issues and develop effective solutions. A proactive process also helps to prevent future incidents and demonstrates your commitment to continuous product improvement and patient safety.
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
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.
Medical Device Product Lifecycle
Working with Qinecsa for Your Needs
We understand that timely responses matter, which is why we offer sustained and high quality support to address urgent incidents and reporting requirements. By choosing Qinecsa as your partner, you gain access to expert guidance that helps protect patients, preserve your company’s reputation, and maintain regulatory compliance in an evolving global market.
