18 MPM344 Project Risk Management Medical Needs Risk Management Connie Farris 11/21/2018 Table of Contents Project Outline 3 Project Description 3 Method (Agile or Waterfall) 3 Risk Categories 4 Risk Register 6 Project Risk Analyses 9 Qualitative Risk Analysis 9 Project Risk Response Strategy TB 11 Risk Response Strategy 11 Plan for Reviewing Risk Responses 12 Identification of New Risks 14 Project Risk Communications Plan TB 15 Communications Matrix 15 Memo to the Project Sponsor 16 References 17 Project OutlineProject Description The quality gauges of therapeutic devices contain numerous viewpoints, for example, plan control, Risk management, vendor management etc. (Singh, 2017) In this paper we are going to discuss the importance of Risk management for medical devices and steps to perform during the product development stage. Risk management is a critical part of the medical device product development lifecycle. (Singh, 2017) It enables medical device engineers to guarantee that the item is dependable, functions obviously and will be no damage to the patients, administrators or the earth. In other words, the main purpose of the Risk management cycle is to lessen or curb the odds of disappointment in the item. Medical Needs is a company that designs and manufactures medical devices and will be opening a new company and would like for us to do the risk management involved with the materials used for these devices and the design to ensure the devices are compliant to all regulations during production. There are many areas we will cover during this project to ensure that a quality product is available for the public consumer. We are looking at completing this project in less than six months before the manufacturing process commences. We will look at everything from vendor, mechanical and that everything planned before the company is open will be as risk free as possible. Method (Agile or Waterfall) . We will be using an Agile Method to conduct this risk assessment. The agile methodology with more checkpoints, gives you a chance to refine what you are working for the client, and what they are at last given. (Tan, 2016) Agile gives the chance to take what you made, offer it to a customer, and bring out criticism. Considering the input, you can decide if you are going the correct way. (Tan, 2016) If changes are required, you give yourself the chance to adjust and alter. When creating medicinal devices, numerous sources of info that must be contemplated. Distinguish the requirements of the end client however comprehend the potential dangers that the item may present to end clients and guarantee that your item is adequately protected and powerful by structuring risk adjustment into your medical device. When using the agile process, you must understand how the Risk management process fits in, and then consolidate that approach into the project development plan. (Tan, 2016) By using t.

1. 18
MPM344 Project Risk
Management
Medical Needs Risk Management
Connie Farris
11/21/2018
Table of Contents
Project Outline 3
Project Description 3
Method (Agile or Waterfall) 3
Risk Categories 4
Risk Register 6
Project Risk Analyses 9
Qualitative Risk Analysis 9

2. Project Risk Response Strategy TB 11
Risk Response Strategy 11
Plan for Reviewing Risk Responses 12
Identification of New Risks 14
Project Risk Communications Plan TB 15
Communications Matrix 15
Memo to the Project Sponsor 16
References 17
Project OutlineProject Description
The quality gauges of therapeutic devices contain numerous
viewpoints, for example, plan control, Risk management,
vendor management etc. (Singh, 2017) In this paper we are
going to discuss the importance of Risk management for
medical devices and steps to perform during the product
development stage. Risk management is a critical part of the
medical device product development lifecycle. (Singh, 2017) It
enables medical device engineers to guarantee that the item is
dependable, functions obviously and will be no damage to the
patients, administrators or the earth. In other words, the main
purpose of the Risk management cycle is to lessen or curb the
odds of disappointment in the item.
Medical Needs is a company that designs and manufactures
medical devices and will be opening a new company and would
like for us to do the risk management involved with the
materials used for these devices and the design to ensure the
devices are compliant to all regulations during production.
There are many areas we will cover during this project to ensure
that a quality product is available for the public consumer. We
are looking at completing this project in less than six months
before the manufacturing process commences. We will look at
everything from vendor, mechanical and that everything planned
before the company is open will be as risk free as possible.
Method (Agile or Waterfall)
. We will be using an Agile Method to conduct this risk
assessment. The agile methodology with more checkpoints,

3. gives you a chance to refine what you are working for the
client, and what they are at last given. (Tan, 2016) Agile gives
the chance to take what you made, offer it to a customer, and
bring out criticism. Considering the input, you can decide if you
are going the correct way. (Tan, 2016) If changes are required,
you give yourself the chance to adjust and alter. When creating
medicinal devices, numerous sources of info that must be
contemplated. Distinguish the requirements of the end client
however comprehend the potential dangers that the item may
present to end clients and guarantee that your item is adequately
protected and powerful by structuring risk adjustment into your
medical device.
When using the agile process, you must understand how the
Risk management process fits in, and then consolidate that
approach into the project development plan. (Tan, 2016) By
using the agile process, even trying to determine any risk that
can take place in each phase of the project, if there is a risk
discovered, it is possible to go back and eliminate such risk
Overall Risk Management Strategy
The strategy being used for risk management will
involve four different steps:
Risk Analysis: Systematic utilization of accessible data to
acknowledge perils and gauge a risk. Risk Estimation: Process
used to allot esteems to the likelihood of occurrence and
seriousness of damage. Risk Assessment: In general process
including a risk investigation and risk assessment. Risk
Evaluation: Procedure of looking at the assessed risk against
given risk criteria to decide the worthiness of the risk. These
four methods will be combined to create a competent risk
management strategy. During every step, the company
representatives and myself will meet weekly to discuss how to
proceed with the specific areas to perform analysis and
estimations in order to come up with the Risk Evaluation. The
idea is to determine all risk throughout this project before the
product is put into place.Risk Categories
In order to comply with the ISO 14971 standards. at the

4. beginning of each design project a design plan is created. The
structure plan ought to incorporate a risk management plan area,
or a different risk management plan will be made. (Fda.gov,
2016) The risk management plan just needs to cover from the
earliest starting point of the venture to item release– not post-
showcase chance exercises. The risk management plan amid the
structure stage will incorporate at any rate the accompanying
components:
. Type of benefit(s): (Fda.gov, 2016) What is the medical
device`s foreseen effect on clinical administration and patient
wellbeing? What benefits were at first foreseen? Was a clinical
preliminary directed? What benefits were normal dependent on
comparable devices?
Magnitude of benefit(s): (Fda.gov, 2016) For each benefit
assessed: What was the medical devices’ initially foreseen
effect on patient wellbeing and clinical administration? What
was the initially foreseen impact of the device on patient
administration and personal satisfaction, probability of survival,
enhancing quiet capacity, averting loss of capacity, or giving
alleviation from the manifestations of the illness or condition?
What was the foreseen size of every treatment impact? What
scale is utilized to straightforwardly quantify the foreseen
advantage? How did the foreseen advantage rank on that scale?
Is the device life supporting or life continuing?
Likelihood of patients experiencing one or more benefits:
(Fda.gov, 2016) What extent of patients was relied upon to
profit by the device? Did the first marking demonstrate which
patients will encounter an advantage? How did the benefits
assessed vary across subpopulations? Was there a variation in
public health benefit for different populations?
Duration of effects: Does the device fix a malady or give a brief
treatment? (Fda.gov, 2016) Could the term, if applicable, of
every treatment impact, be resolved? Provided that this is true,
what was it?

5. Project Risk Identification Project Risks
Project Risks
Cost risk: Cost risk can include material cost, production time,
mechanical failure. At times and depending on the economy,
cost could be a risk that is unforeseen.
Performance risk: The medical device might not perform as
expected and might cause harm to patients, operators and the
environmental strategic risks. The technology chosen for the
medical device may not work resulting in production delay.
Training: If the employees are not properly trained this could
result in faulty devices and delays in production. Not to mention
harm to fellow employees or possibly a customer. This is
another area which could be very costly to the company.
Schedule risk: The medical device development lifecycle may
take longer than expected. It might increase the cost and delay
the project benefits. Several of the risk factors above could play
a big part in schedule delays.
Contractual: Even though a contract has been signed, the terms
of the contract are ambiguous. If there is ambiguity in a series
of contracts, the health plan can incur additional cost in
situations in which it did not expect to have any costs.

6. Risk Register
List the risks in the Risk Register, provide detailed descriptions
of the risks, and discuss the potential impacts on the project if
the risk events occur.
Risk Category
Description of Risk
Potential Impact on Project
Cost
material cost, production time, mechanical failure
Possibly delay of project
Extending Cost
Performance
Device not performing to specs
Possible injury to customer
Time to revise device
Training
Training all employees proper use of mechanical equipment
Injury to fellow employees
Costly to company
Schedule
Device Lifecycle
Increase Cost
Schedule Delays
Contractual
Terms of contract
Incurred Additional Cost
Risk source and description
Risk Source
Description
Risk repository
The hazard store is the history information containing the
rundown of dangers distinguished for finished ventures. The
hazard store can be utilized to land at a rundown of potential

7. dangers for the undertaking.
This archive can likewise be sifted dependent on the hazard
sources, classifications, and undertakings.
Checklist analysis
The risk identification checklist is a questionnaire that helps
identify gaps and potential risks. It is developed based on
experience and project type.
Expert judgment
Hazard recognizable proof is likewise done by conceptualizing
with or meeting experienced ventures members, partners, and
subjects matter specialists.
Project status
The venture status incorporates ventures status meeting
reports, status reports, advance reports, and quality reports.
These reports give the current project advance, issues
confronted, and edge infringement. These give understanding
into the status of the task and potential new hazard
Project Risk Analyses Qualitative Risk Analysis
Perform a qualitative risk analysis on the risks, and determine
the priority of the risks using the probability and impact matrix.
Impact rating
A=high (rating 100)
B=medium rating (rating 50)
C=low (low rating 10)
Probability occurrence (in percentage)
A= 80-100
B= 60-80
C=30-60
D=0-30

8. Risk event
Probability of Occurrence
Potential Impact
The hardware will be delivered in 10 days late, this will lead to
an overall project delay of 10 days
100%
B 50
The hardware will be delivered in 10 days late, this will lead to
an overall project delay of 10 days in a minor importance to the
customer
100%
B 50
The acceptance test scope of work is not confirmed by the
customer by the customer in the integration test
70%
B 35
At certain level, the customer confirms the half features
described in the product but informs the firm the other half as
well as other additional requirements
80%
B 45
Project Risk Response Strategy Risk Response Strategy
Describe the risk response strategies for each of your risks.

9. Risk Category
Risk Response Strategy
Description of Risk Response
Cost
Stakeholders, Vendors and other personnel involved are aware
of possible cost and are working together to stay within the
initial budget
Make sure that the requirements specification has been reviewed
by all concerned parties and is internally agreed that the time
frame to complete this project is feasible
Performance
Having the board assure that are machines used and materials
needed meet all
State and Federal Requirements
The main contractor will be inspecting all materials and tools to
be used in the manufacturing of the medical devices
Training
The Lead Manager will ensure all employees know the proper
use of all equipment to be utilized
Human resources will provide ongoing training to ensure safety
measures and that quality products are produced
Schedule
Proper management
Dispensing with the risk
Bringing down the likelihood of risk event
Bringing down the effect of the risk on the task destinations
Contractual
Stakeholders and Vendors,
Contractors and Project Manager
There will be a solid contract between the stakeholders,
vendors, contractors and project manager with straight forward
consequences if contract is not kept.

10. Project Risk Controlling TBPlan for Reviewing Risk Responses
The risk reaction arranging includes deciding approaches to
diminish or take out any dangers to the undertaking, and
furthermore the chances to build their effect. Task supervisors
should work to take out the dangers previously they happen.
Likewise, the venture chiefs should work to guarantee that open
doors happen. In like manner, the task administrator is likewise
dependable to diminish the likelihood and effect of dangers and
increment the likelihood and effect of chances.
For the dangers that can't be relieved, the venture administrator
needs a vigorous alternate course of action and furthermore a
reaction plan if possibilities don't work. It isn't required to take
out every one of the dangers of the venture because of asset and
time limitations. An undertaking director should survey
hazard all through the venture. Getting ready for dangers is
iterative. Subjective risk, quantitative risk, and risk reaction

11. arranging don't end ones you start chip away at the venture.
Risk Response Strategies
The decisions of reaction systems for THREATS include:
Maintain a strategic distance from: Focus on dispensing with
the reason and consequently, wiping out the risk.
Moderate: There are sure dangers that can't be killed.
Nonetheless, their effect can be lessened. This is named as
relief of dangers.
Exchange: Transfer the risk to some other gathering. Protection
buys, guarantees, ensures, and so forth are instances of risk
exchanges
The decisions of reaction systems for OPPORTUNITIES
include:
Adventure: Add work or change the undertaking to ensure the
open door happens
Improve: Increase the likelihood and positive effect of risk
occasions
Offer: Allocate responsibility for to an outsider
A reaction procedure for BOTH dangers and openings:
Acknowledge: Passive acknowledgment leaves activity to be
resolved as required, if there should arise an occurrence of a
risk occasion. Dynamic acknowledgment may include
emergency courses of action to be actualized whether chance
happens and designation of time and cost stores to the
undertaking. A choice to acknowledge chance must be conveyed

12. to partners.
Heighten: Risks which can't be checked and dealt with by the
venture are raised to the upper dimension, for instance to
program the executives.
At whatever point the task chief is reacting to dangers or
openings:
Execution of procedures must be time-bound
Exertion chose must be suitable to the seriousness of the risk
A solitary reaction can be a demonstration of numerous risk
occasions
A technique can be chosen by the task chief as well as by the
group, the partners and specialists
Yields of Plan Risk Responses
Risk enlist, venture the executives designs and undertaking
archives should be refreshed as yields of Plan Risk Responses.
Task Management Plan Updates
Task Management Plan can be refreshed by new work
exercises/bundles that could be included, expelled, or doled out
to various assets, along these lines, making arranging an
iterative procedure
Identification of New Risks
Recognize the high-chance errands, examine those assignments
that are well on the way to take longer than anticipated, end
past their complete dates, defer the begin or complete of
different undertakings, or cause the venture to complete late

13. Distinguish the spending dangers. View and handle those
undertakings that are over spending plan, prone to end up over
spending plan, or liable to make the entire venture go over
spending plan.
Distinguish the asset chances your task might be in danger on
the off chance that you are utilizing assets that are
exceptionally specific or just accessible through constrained
providers, if the assets are not being utilized proficiently, or on
the off chance that they are taking a shot at different activities.
Characterize your dangers After you recognize potential
dangers, you can utilize Microsoft Office Project Web Access to
catch risk data with the goal that you can examine the effect of
dangers if they happen.
Project Risk Communications Plan TBCommunications Matrix
Complete the communications matrix for discussing risk
elements with your stakeholders.
Stakeholder
Risk Content
Method
Frequency
Project Managers, Team Members
cost
email
As required
Program Manager, Project Managers
performance
memos
weekly
Program Manager
training

14. Manager program control file
As needed
Program Director,
schedule
email
As required
Project Sponsor
Vendor
Contractor
Contractual
Email
Phone
Meetings
Weekly
Memo to the Project Sponsor
References
Fda.gov. (2016). Factors to Consider Regarding Benefit Risk in
Medical Device Product Availability, Compliance, and
Enforcement Decisions. [online] Available at:
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulati
onandGuidance/GuidanceDocuments/UCM506679.pdf
Project Management Institute. (2009). Practice standard for
project risk management. [VitalSource version]. Retrieved from
https://online.vitalsource.com/#/books/9781933890388/cfi/0!/4/
[email protected]:0.00
Project Management Institute, A guide to the project
management body of knowledge (PMBOK® guide), Fifth
Edition, Project Management Institute Inc. 2013. [VitalSource
version]. Retrieved from

15. https://online.vitalsource.com/#/books/9781935589815/cfi/0
Singh, H. (2017). Role of Risk Management in Medical
Devices. Retrieved from https://www.einfochips.com/blog/a-5-
step-guide-to-risk-management-for-medical-devices/
Tan, J. (2016). How Agile Project Management Can Improve
Your Medical Device Development. Retrieved from
https://www.meddeviceonline.com/doc/how-agile-project-
management-can-improve-your-medical-device-development-
0001
Coombs, W. T. (2014). Ongoing crisis communication:
Planning, managing, and responding. Sage Publications.
Ruan, X., Yin, Z., & Frangopol, D. M. (2015). Risk matrix
integrating risk attitudes based on utility theory. Risk
Analysis, 35(8), 1437-1447.
By Lavanya, N. | Malarvizhi, T (2008) Risk analysis and
management
a vital key to effective project management. Retrieved from:
https://www.pmi.org/learning/library/risk-analysis-project-
management-7070