Medical Device Reporting (MDR) - By Compliance Global Inc.

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Toll Free 1-844-746-4244 support_at_complianceglob
al.us
Compliance Global Upcoming Webinar

• .

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Medical Device Reporting (MDR)
Speaker Jerry Dalfors Thursday , August 20th
0100 PM EST
Compliance Global Inc 2015


www.ComplianceGlobal
.us
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Upcoming Webinar of Jerry
Dalfors Medical Device Reporting (MDR) Thursday
, August 20th 0100 PM EST Overview Manufactur
ers of Medical Devices are required to report to
the FDA when they learn that any of their devices
may have caused or contributed to a death or
serious injury. Manufacturers must also report to
the FDA when they become aware that their device
has malfunctioned and would be likely to cause or
contribute to a death or serious injury if the
malfunction was to be reoccur. The Medical Device
Reporting (MDR) regulation (21 CRF 803) contains
mandatory requirements for manufacturers,
importers, and device user facilities to report
certain device-related adverse events and product
problems to the FDA. Importers Importers are
required to report to the FDA and the
manufacturer when they learn that one of their
components that are used to produce or assemble
the final device may have caused or contributed
to a death or serious injury. The importer must
report only to the manufacturer if their imported
devices have malfunctioned and would be likely to
cause or contribute to a death or serious injury
if the malfunction were to reoccur.
Compliance Global Inc 2015



www.ComplianceGlobal.us
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Upcoming Webinar of Jerry
Dalfors Medical Device Reporting (MDR) Thursday
, August 20th 0100 PM EST Why Should You
Attend The FDA expects health care
professionals, patients, caregivers and consumers
to submit voluntary reports about serious adverse
events that may be associated with a medical
device, as well as use errors, product quality,
and therapeutic failures. The overall intent of
this webinar, just like FAA for passenger safety
is to provide critical information that helps
improve patient safety.
Compliance Global Inc 2015



www.ComplianceGlobal.us
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Upcoming Webinar of Jerry
Dalfors Medical Device Reporting (MDR)
Thursday , August 20th 0100 PM EST Areas
Covered in the webinar We are going to talk at
length about Customer Complaints a little later
in this webinar. Each manufacturer must establish
and maintain procedures to control all documents
that are being used for the generation and
distribution of medical devices. To meet Quality
System guidelines (expectations, regulations,
etc.) , procedures need to provide but not
limited to the following 1 Medical device
reports are submitted to the FDA by mandatory
reporters (manufacturers, importers and device
user facilities) and voluntary reporters (health
care professionals, patients, caregivers and
consumers). (a) Document approval and
distribution. Each manufacturer need to designate
an individual(s) to review for adequacy and
approve prior to issuance the documents
generated to meet the requirements of the Quality
System generated to be compliant with 21 CRF 820.
The approval, including the date and signature of
the individual(s) approving the document, are to
be documented. Documents established within a
company should be available at each location
within the company as applicable, important to
know and understand the difference between
Policies, Practices (internal guidelines) and
Procedures. Procedures require documented
evidence of compliant performance by operators.
Compliance Global Inc 2015



www.ComplianceGlobal.us
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Upcoming Webinar of
Jerry Dalfors Medical Device Reporting (MDR)
Thursday , August 20th 0100 PM EST Learning
Objective Each year, the FDA receives several
hundred thousand medical device reports of
suspected device associated deaths, serious
injuries and malfunctions. Medical Device
Reporting (MDR) is one of the post market
surveillance tools the FDA uses to monitor device
performance, detect potential device-related safet
y issues, and contribute to benefit-risk
assessments of medical devices. Who Will
Benefit Quality Assurance (QA)
Professionals Operations Management
Professionals Medical Device distributors
Consumers, Patients
Compliance Global Inc 2015



www.ComplianceGlobal.us
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Upcoming Webinar of Jerry Dalfors Medical
Device Reporting (MDR) Thursday , August 20th
0100 PM EST Level Beginner Speaker
profile Jerry Dalfors has extensive (40 years)
of business administration, consultative,
technical and managerial experience in the
development and manufacture of highly regulated
biopharmaceutical products including injectables,
biologics, medical devices and oral dosages. View
More
Compliance Global Inc 2015



www.ComplianceGlobal.us
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Compliance Global Inc 2015



www.ComplianceGlobal.us