Post Marketing Surveillance(PMS) for Medical Device | CAPA compliance

Medical Device Post Marketing Surveillance

Post Marketing Surveillance (PMS) is the practice of monitoring the safety of a medical device after it has been released on the market. Post-marketing surveillance guidelines is a collection of processes & activities used to monitor the safety & effectiveness of medical devices. These activities are designed to generate information to quickly identify poorly performing devices & other safety problems & accurately characterize real-world device performance & clinical outcomes. The post marketing surveillance includes, the handling of the customer complaints, handling of the CAPA arising from the Customer complaints.

The services include but not limited to the following :

CAPA Management

The CAPA system is the cornerstone of a Quality Management System, especially in the Pharmaceutical/Medical Device Industry, and the backbone and driver for Quality improvements. The CAPA system feeds the Quality System to improve processes, procedures, organization and business in a structured, well-documented and actionable way.

Audit Report and Compliance

In order to ensure the compliances, there may be various kinds of audits like audits conducted by the customers, USFDA, Notified Bodies, TGA or even the effective internal audits may give a good insight for the management to know the status of the Quality Mangement System and its effectiveness.

Customer Complaint Handling

When a customer complains, it is the important part for every organization to take care of their customer as it is usually for a good reason or genuine concern. We never avoid complaints; we take care of our customers by listening to their complaints, and resolving it, to ensure a happy customer.

Resolve Your Problems For Any Post Marketing Support

Our Other Services

Manufacturing Site Design and Conceptualization

QMS & Certification

Regulatory Compliances

Medical Device/Drug-Device Combination Product Design & Development


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