Risk Management

Complete guide
How to integrate
Risk Management
activities in Design
and Development ?
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1. Integrate risk from the Planning
stage
Design activities
Risk
Risk
Mngmt. inter-relationship(s) between risk
management activities and D&D activities
Questions to ask:
How can we effectively integrate risk

management with our project's design and
development processes?
What expertise and resources are needed to

address safety concerns in our design and
development stages?
Risk Mngmt.
D&D plan
plan Coherence and Connection
2. The outputs of risk management
serve as Design inputs
Design characteristics,
specifications ...
Risk control Design
measure(s) input(s)
Need(s) for risk control
measures
Harm(s)
D&D
Identifying hazards
process
Risk analysis
Risk
Mngmt.
When risk control measures are determined to be

necessary and are initially defined, these become
an output as part of the iterative cycle.
3. Design ouput & Risk control
measures
D&D outputs are generally of 3 types :
Examples of risk control

D&D output type
measure(s)
1. Medical device characteristics Compliance with IEC 60601

including those essential for its Over-temperature alarm
safe and proper use User training ...
Special quality requirements

2. Requirements for purchasing, in contracts
production, handling, Imposing stringent process
distribution and servicin controls
Environmental requirements...
Electrical safety performance

limits (e.g., leakage current,
3. Medical device acceptance insulation strength)
criteria Contamination levels or
sterility requirements for a
device or accessory...
Design outputs for a medical device will specify

risk control measures and their application.
When inherent safety is not feasible, additional

measures like labeling, training, and risk
communication are needed, applicable
throughout the device's life-cycle.
4. Use the Design review as a
checkpoint
Design review
Hazards Have all hazards been identified, risks assessed,

identification and risk control measures identified?
Have design and development reviews ensured

Residual adequate communication of individual and
risk(s) overall residual risks to relevant parties,
including users?
Have the effectiveness of risk control measures

Effectiveness for individual risks been verified?
Have design validation activities effectively

Design assessed the overall residual risk associated with
validation device usage by the intended user?
Have new risk-related issues identified during the

New risk design transfer process been controlled and
verified?
Have the reviews confirmed the validity of

Risk/benefit risk/benefit decisions regarding the acceptance
of the overall residual risk?
5. D&D verification, the proof that
risk control measures are
implemented
D&D
verification
What ?
Objective
evidence
Why?
Risk control For each

measures risk(s)
How?
Effectiveness
6. D&D validation, the proof that
the risk control measures are
appropriate
Risk control User needs

measures
Validation
activitie(s)
Analytical
techniques
Validation
plan(s)
Risk control measures need to be established

and addressed prior to conducting clinical
trials/investigations.
7. D&D changes, are there any new
risks?
Reviewed New risk(s)?
Verified
Modification
or new risk
D&D changes control
measure(s) ?
Validated
Benefit/risk
Approved
acceptable ?
Prior to implementing a proposed change, it is

important to ensure that any individual residual
risk(s), as well as the overall residual risk, are
defined and remain acceptable.
8. D&D transfer, are there any new
risks?
D&D transfer
Conception Production
Risk control New risk(s)?

measure(s)
Implemented &
effective
4 Things to remember :
Medical device design focuses on risk identification
and control, aiming to balance risk, functionality,
and feasibility.
Early risk management in design prevents

problems and includes assessing risks in various
conditions.
The design process iterates input, output, and

verification to manage and maintain acceptable
risk levels
Post-market, medical devices require integrated

risk and quality management, with thorough
documentation linking design to risk
Did you like this guide and its
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book.
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Complete guide

Ring the to never miss a post.

How can we effectively integrate risk

What expertise and resources are needed to

When risk control measures are determined to be

Examples of risk control

1. Medical device characteristics Compliance with IEC 60601

Special quality requirements

Electrical safety performance

Design outputs for a medical device will specify

When inherent safety is not feasible, additional

Hazards Have all hazards been identified, risks assessed,

Have design and development reviews ensured

Have the effectiveness of risk control measures

Have design validation activities effectively

Have new risk-related issues identified during the

Have the reviews confirmed the validity of

Risk control For each

Risk control User needs

Risk control measures need to be established

Reviewed New risk(s)?

Prior to implementing a proposed change, it is

Risk control New risk(s)?

Early risk management in design prevents

The design process iterates input, output, and

Post-market, medical devices require integrated

✔️Access 365 questions to

✔️Access the list of expected

✔️Be guided by +72 flowcharts to

✔️Lifetime updates in case of

155 pages, digital download

Follow me for Regulatory & Quality

Ring the to never miss a post.

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