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Regulations

Regulations

Design Control

Design Control

Quality Management

Quality Management

Manage Customers and Customer Sites (PMS)

Post-Market Surveillance is defined as a series of activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices marketed in the USA/European Union for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions. Orcanos Service Center is integrated to the ALM and Quality Management system. Its the place were your customers can report service calls, which can be later addressed by your support team.

  • Orcanos Service Center is easy to use, simple to configure, and seamlessly integrated to other Orcanos modules.
  • One-stop Integrated Helpdesk Ticketing/Complaints, Quality and ALM
  • Fully Customized to match organization needs
  • Manage service call lifecycle and create custom statuses
  • Address Risks and safety issues up to mitigation, CAPA and more
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Define Service Call/PMS Workflow

The Service Call Workflow is initiated when a customer or agent enters a new service request. Service call ssign an agent to handle this request. Based on the predefined workflow, the system automatically routes the service request to relevant stakeholders, until resolution. Many companies will already be monitoring historical data from adverse events, consumer complaints and service calls which is viewed as "reactive". The significant new requirement in MDR regulation is the introduction of the proactive requirements. Market Surveillance is the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant USA/European Union harmonization legislation and do not endanger health, safety or any other aspect of the protection of public interest.

Customer Service Dashboard

Track customers service calls using filters, Google map, and many other professional dashboard panels

  • Missed Service calls
  • Service calls related to complaints
  • Service calls by customer/distributor
  • Open vs. Closed Service calls
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Your next electronic audit with Orcanos

Assure your success……

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