Post-Market Surveillance (PMS) is the practice of monitoring the safety of a medical device after it has been released on the market. Post-market surveillance is a collection of processes & activities used to monitor the safety & effectiveness of medical devices. Improve productivity and efficiency of supply chain management. Reduce cost of compliance streamlining and standardising processes. These activities are designed to generate information to quickly identify poorly performing devices & other safety problems & accurately characterize real-world device performance & clinical outcomes.
Operon Strategist helps manufacturers design a PMS plan specific to a product or family of products. We also guide manufacturers in establishing an effective adverse event reporting system so that information regarding an adverse event reportable event can be easily conveyed to regulatory bodies as well as the public.
We Provide Medical Device Post Market Support includes Following stages: Ongoing system and maintain the compliances during an ongoing commercial manufacturing process. CAPA compliance. Audit Report & Compliance. Labelling Compliance. Clinical Evaluation & Post Marketing Surveillance. Medical Device Reporting. Customer Complaints. We can handle such incidences very effectively and efficiently. Design Output, Design verification & Design Validation.
Medical device vigilance & medical device reporting are two of most commonly used methods for reporting adverse events in the EU & US respectively. Other sources for gathering information includes product or customer surveys, literature review, service reports, regulatory filings, etc.