Customer Service & Post-Market Surveillance

Orcanos Customer Service & Post-Market Surveillance is a module within the Orcanos platform designed to help medical device companies achieve MDR compliance for post-market surveillance (PMS) and market surveillance. It is built for quality and regulatory teams that need to manage customer service calls, complaints, and adverse events within a single, integrated environment.

The module integrates directly with the Orcanos ALM and Quality Management system, providing a unified helpdesk and ticketing solution that connects customer-reported issues to quality processes such as CAPA, risk management, and design control.

Customer and Site Management

• Provides a service center where customers can report service calls, which are then addressed by a support team.
• Manages the full service call lifecycle with customisable statuses.
• Functions as a one-stop helpdesk for ticketing and complaints across Quality and ALM workflows.
• Addresses risks, safety issues, mitigations, CAPA, and related quality activities from within the same system.

Service Call and PMS Workflow Configuration

• Service calls can be initiated by customers or agents for new service requests, with automatic assignment to a handling agent.
• Predefined workflows automatically route service requests to relevant stakeholders through to resolution.
• Supports proactive PMS requirements by monitoring historical data from adverse events, consumer complaints, and service calls.
• Workflow is fully configurable to match organisational processes.

Customer Service Dashboard

• Tracks customer service calls using filters, Google Maps integration, and multiple dashboard panels.
• Monitors calls related to complaints and flags missed service calls.
• Allows filtering of calls by customer or distributor.
• Provides a clear view of open versus closed service calls.

The module is part of the broader Orcanos platform and is designed to integrate with Quality Management and Design Control processes, supporting end-to-end MDR compliance for post-market surveillance activities.