Procedure 16
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POST-MARKETING SURVEILLANCE
1. SCOPE
1.1.
This procedure details the company's post-marketing surveillance activities.
2. RESPONSIBILITY
2.1 The Quality Representative is responsible to ensure that Post-Market Surveillance activities
occur.
3. DETAILED INSTRUCTIONS
3.1
Post-Market Surveillance includes:
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Customer survey
Customer complaints
Literature search related to Clinical Evaluation Report (CER) preparation and
Management Review Meetings
3.2 On an annual basis, Dentonics will contact customers via a written Customer Survey in order to
determine the quality of products and service as viewed by Dentonics' customers. Surveys may
be sent to a customer via e-mail, fax, or U.S. Mail.
3.2.1 A cross-sampling of customers will receive the survey based on the following criteria:
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Customer ordered at least $2,000.00 in products from Dentonics for the prior year
Customer placed at least 6 orders with Dentonics for the prior year
Not all customers who meet the above criteria will be surveyed.
3.2.2 Once the completed surveys are received back, the Quality Representative will review the
results and determine if actions are necessary.
3.3 The Corrective and Preventive Action (CAPA) System is used to identify and document customer
complaints related to Dentonics, Inc. products and processes. This data is compiled and
monitored for trends and presented at each Management Review Meeting.
3.3.1 See Procedure 10 for details of the Corrective and Preventive Action (CAPA) System.
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