Once regulatory approval has been obtained to market a medical device, the post-market activities commence in earnest. To ensure continuous monitoring of your device in clinical use, specifically relating to safety, performance and efficacy, the following systems are required depending on the classification of your device:
- Safety and vigilance/medical device reporting for both clinical and commercial devices.
- Post-Market Surveillance planning and reporting.
- Post-Market Clinical Follow Up planning and reporting.
- Periodic Safety Update Reports.
- Recall systems and reports.
- Summary of Safety and Clinical Performance.
Regulatory Affairs ›
Considering the global regulatory impact of operational and business decisions on the business is key to the success of the business ...Read more ›
Design Assurance ›
The product development process is a structured approach, which if adhered to, can have significant influence on a smooth regulatory approval process ...Read more ›
Clinical Affairs ›
Depending on the novelty, intended use and risk level of your medical device, you may need to perform a clinical investigation ...Read more ›