3.5.

6 Medical device life cycle steps

Each step of the medical device life cycle is taken into account in the risk management process:
Step Main activities Participants
Conception Selection of composite Multiwave Imaging
electromagnetic properties
Selection of particles
Selection of solvent
Selection of composite weight
ratio
Selection of pouch material
Selection of label material
Sealing process
Selection of packaging
IFU/labeling text
Supply-chain Selection of suppliers Multiwave Imaging,
(raw materials or suppliers
intermediate products)
Quality control upon receipt
Storage
Production Preparation of working Multiwave Imaging
environment
Pouch preparation
Composite insertion into the
pouch
Leveling process
Vacuum process
Sealing process
Cleaning process
Labeling process
Quality control before release
Conditioning process
Supply-chain Storage Multiwave Imaging,
(finished products) transportation company
Transportation to customers
Clinical use MRI scan End-users
Storage
Cleaning
Product Returns (end-of-life Disposal/recycling Multiwave Imaging, end-
or defective devices) users

3.6 RISK ANALYSIS

 3.6.1 Method used to analyze risk
The risk analysis method is based on 4 steps:
1. Identification of safety features, hazards associated with the device, hazardous situations, or
possible harm to the patient or users or environment (§4.3). The list of hazards provided in
annex E of the standard may be used for hazard identification.
2. Evaluation of the probability of occurrence of each hazardous situation, and the severity of the
resulting harm (§4.4 and 4.5)
3. Description of the control options (by design, protective measures, information for safety)
(§6.2 and 6.3)
4. Residual risk evaluation and risk/benefit analysis (§6.4, 6.5 and 6.6)
The 4 steps are documented in an Excel file TF-520 Risk analysis matrix, allowing the risk project team
to follow the entire risk assessment process.
Note: one hazardous situation may cause more than one type of harm. The most serious harm is always
considered when performing risk evaluation.
3.6.2 Risk control options
There are three risk control options used to reduce risk (listed in order of priority):
1. Inherent safety by design;
2. Protective measures in the medical device itself or in the manufacturing process;
3. Information for safety.
Evidence must be provided to demonstrate the efficacy of risk control options.
According to the EU Directive 93/42/EEC, control measures are put in place in order to reduce the risks
as far as possible (i.e. the AFAP method: As Far As Possible).
According to the EU Directive 93/42/EEC and Annex ZA 7.c) of the EN ISO 14971:2012 standard, the
information given to users does not solely allow for additional risk reduction.
If needed, an action plan may be written regarding the application of risk control methods.
3.6.3 Risk quotation criteria
Risk is defined as the combination of the severity of possible harms to the patient or user and the
probability of occurrence of each harm.

3.6.4 The severity scale

Severity is the measure of the possible consequences (damage, harm or adverse health effect)
of a hazard. Here, a ranking scale from 1 to 4 is used to rank the severity of a potential harm.
 Severity level Description Possible harm to user/patient
• Discomfort
Reversible alteration without medical
1: Negligible • Dissatisfaction, loss of time
care
• Infinitesimal local warmth
Reversible light alteration requiring • Minor skin injury
2: Moderate
medical care • Minor local skin irritation

• Major skin/bone injury

• Allergic skin reaction
• Respiratory tract irritation
• Other limited health risks due to
inhalation/ingestion of harmful
3: Significant Reversible severe alteration
chemical component
• Viral or bacterial infection
• Wrong diagnostic leading to
inadequate treatment or unnecessary
additional tests

3.6.5 The probability of occurrence scale

The likelihood ranking, also a scale from 1 to 4, indicates the probability of occurrence of a
harm.
Probability level Qualitative likelihood Quantitative likelihood
1: Improbable An event that is very unlikely to < 1 in 1000 devices
happen < 0.1%
2: Rare Unlikely to occur during total Between 1 in 1000 and less than 1 in 100
operational life but may rarely devices
occur when considering all 0.1% - 1%
devices
3: Probable May occasionally occur when Between 1 in 100 and less than 1 in 10
considering all devices devices
1% - 10%

4: Frequent Likely to occur at least once ≥ 1 in 10 devices

during operational life of the ≥ 10%
device