Abstract tested manufactured, labeled, prescribed, dispensed, and used


This research case study
considers the following question: “Why Implementation
of Risk Management in the medical devices is necessary?” The hypothesis
governing this research case study a safe product is one that has reasonable
risk, given the magnitude of the benefit expected and the alternatives
available. Medical device manufacturers, the Food and Drug Administration (FDA)
and medical device users have an important role to play in maintaining this
risk-benefit balance, by making sure that products are developed, tested
manufactured, labeled, prescribed, dispensed, and used in a way that maximizes
benefit and minimizes risk. 

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                       The development of medical devices involves
activities for maximizing the benefit and minimizing risks in its intended use.
In the medical device industry the major issues that are being faced are the
product liability and regulation. The major probability of clinical risk
suffered by patient is due to the damage happening during the delivery health
care services.

                    Safety of the medical
products is the responsibility of the medical device manufacturers however
safety does not always mean “zero risk”. Therefore it is useful to follow the
patient safety definition provided by Emanuel and Berwick: “Patient safety is a
discipline in the health care sector that applies safety science methods toward
the goal of achieving a trust worthy system of healthcare delivery. Patient
safety is also an attribute of healthcare systems; it minimizes the incidence
and impact of, and maximizes recovery from, adverse events.”


Management on Medical Devices

device manufacturers must be able to select the risk management activities that
are suitable for their type of product, and employ them at phases where they
are most appropriate and effective. As of figure 1 the risk management process
includes the following steps: Risk Analysis, Risk assessment, Risk control, and
Production & Post production information.

Figure: 1 Risk Management Process

                      In general, management is
required to identify the risk management team; to establish a process for
establishing acceptable risk levels; to provide appropriate personnel to carry
out the process; and to review the process on a regular basis. Our problem is
to understand how risk management activities currently influence the
development of medical device.


Device Classification

          They classified according to the
potential risk that they might impose on the users and are also based on FDA’s
level of regulatory control to release and market the device. The higher the class, the higher is the
risk and the higher is the number of regulatory controls. Medical devices
can be classified into three categories: –


Ø  Class

Lowest Risk

     These devices have the lowest risk as they
are not complicated. They are also simple and safe to use and they are only
subject to general controls.


Ø  Class

Riskier than class I

     They require both genera controls and
special controls. These are riskier then class I and these may be used for
supporting human life.


of class II devices are X-ray, pumps and surgical drapes.


Ø  Class

Most riskiest

                 This is the most riskiest
among the classes of medical devices as these devices are used for sustaining
human life. Generally devices under these class III categories are usually
required to have both a Pre-Market Approval (PMA) and 510(K) clearance for
market submission.

Examples of class III
devices are replacement heart valves and silicone gel-filled breast implants.




                 Integration of risk management
within a quality management system can be an advantage for manufacturers of
medical devices in order to comply with regulatory requirements.                        Now day’s
international medical devices regulatory bodies incorporate requirements that
are either included in that standard or are consistent with the standard. Those
requirements are included either as part of the design requirements or part of
the overall medical device management process in regulations in various