1. POST MARKETING SURVEILLANCE FOR
MEDICAL DEVICE
Malesh M
www.i3cglobal.com

2. POST MARKETING SURVEILLANCE (PMS)
Post Marketing Surveillance (PMS) is the practice of monitoring the
safety of Pharmaceutical or Medical device after it has been released
on the Market. Post Marketing Surveillance uses a number of
approaches to monitor the safety of licensed drugs and Medical
Devices, including spontaneous reporting databases. These data are
reviewed to highlight potential safety concerns in the process. Through
its premarket review process, assure that the risk associated with
medical device have been minimized when those device first enter the
market. The source of Post Marketing Surveillance for Medical Device
includes,
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+91 9900 3218 14

3. POST MARKETING SURVEILLANCE (PMS)
Customer feed back
The feedback data include feedback on indication of use, instructions
for use and customer satisfaction. A customer feedback format seeking
opinion on all above aspects is sent to the customer with a request to
return duly filled. When customer does not respond for any reason, the
marketing team collects opinion verbally during a meeting or on phone
and details entered in the format. Data collected are analyzed through
use of any suitable techniques. The results of analysis is shared with
others contributing to satisfaction/ dissatisfaction for deciding causes
and to initiate corrective actions, wherever necessary.
Customer complaints
Customer complaints/Advisory Notices will be forwarded to the
respective department through the sales department. All customer
complaints/Advisory Notices will be acknowledged by mail within one
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+91 9900 3218 14

4. POST MARKETING SURVEILLANCE (PMS)
working day. Subsequently the pertinent functional heads shall resolve
the complaint if required
through direct interaction with the
customer/customer representative/or by advisory notes (call back).On
closure
of
the
complaint,
intimation
to
that
effect
shall
be
communicated to the sales department. Reporting shall include the
adherence to production schedule, status of development parts and
improvement projects identified and their status. Analysis of customer
complaints helps to detect the manufacturing problems, Product
quality improvements, Knowledge of long term performance or
complications etc.
Reports from regulatory authorities
Reports of incidents from regulatory bodies for a similar device
manufacturer can be reviewed if available.NC Reports of audits can be
used as a feed back for post market experience. Review of these data
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+91 9900 3218 14

5. POST MARKETING SURVEILLANCE (PMS)
is considered as an information which can be an early warning for the
quality issues of the product and it is communicated immediately to
the concerned people if necessary
Literature review
Literature of the similar devices is an important source of post market
surveillance. Journals regarding devices are reviewed and information
collected and documented.
In house testing
Stability studies carried out on the device proves the long term
stability of the device. Sampling and testing of device is carried out as
per the standard operating procedure for stability studies
Failure analysis
Failure analysis carried out for the products and CAPA implemented
also provides information regarding the post market surveillance
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+91 9900 3218 14

6. POST MARKETING SURVEILLANCE (PMS)
Post market surveillance report
Achievements of PMS system shall include the following
 Detection of manufacturing problems
 Product quality improvement
 Confirmation of risk analysis
 Knowledge of long term performance or complications
 Customer satisfaction
 Performance in different user populations etc.
Based on the post market surveillance through Feed backs, Customer
complaints, Regulatory reports ,literature review ,in house testing and
Failure analysis an annual report is prepared which is communicated
annually through the management review meetings .Based on the
report additional points can be included in Risk management process.
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+91 9900 3218 14