EVELABS TECHNOLOGIES PVT LTD Risk Management Plan | Number RMP001

Version 0.1
Status - Draft

RISK MANAGEMENT PLAN

Reference Number - 001
PLAN APPROVALS
Description Name / Title Signature Date
Prepared by RAHUL UNNIKRISHNAN 2-10-2017
Reviewed by
Approved by

REVISION HISTORY
REVISION LEVEL REVISION DATE DESCRIPTION
0.1 2-10-2017 Draft Released


 EVELABS TECHNOLOGIES PVT LTD Risk Management Plan | Number RMP001
Version 0.1
Status - Draft

Table of Contents

Purpose 3

Scope 3

Responsibility 3

Qualification of Personnel 4

Objectives of Risk Management Activities 4

Background 4

References 5
Internal References 5
Standard and Regulatory References 5

Risk Management Plan 6

Criteria for acceptability 7

 EVELABS TECHNOLOGIES PVT LTD Risk Management Plan | Number RMP001
Version 0.1
Status - Draft

1. Purpose
The purpose of the Risk Management Plan protocol is to define the risk management
activities planned during the product development process for DRIPO - an infusion
monitor .

2. Scope
The scope of the risk management plan relates to the activities and documentation
pertaining to the product risks. The scope of risk management is limited to DRIPO, its
interface with other products and components, and use during gravity drip infusion
for monitoring purpose.

3. Responsibility

Department/Person Roles and Activities

RA/QA Establishing and maintaining risk management

documentation

Project Team Participating in risk management activities

Project Manager Assuring that all risks are

identified, documented and mitigated to
an acceptable level

Obtaining Executive Management

approval for risk management activities

Maintaining the Risk Management File

(RMF)

Executive Management Approval of Risk Management Plan

4. Qualification of Personnel
The personnel who participates to the risk analysis is composed of:
Experienced staff who was involved in the design process of similar
products
The expert practitioners who participate to the design process
 EVELABS TECHNOLOGIES PVT LTD Risk Management Plan | Number RMP001
Version 0.1
Status - Draft

5. Objectives of Risk Management Activities

The objective of risk management activities is to deliver a risk analysis report, which
contains:
The device characteristics that could impact on safety (ISO 14971),
The software safety classification (IEC 62304),
The risk analysis table,
The risk traceability matrix with design requirements,
The overall assessment of residual risk.

The risk analysis table and risk traceability matrix will be created and updated as
necessary during development of device.

Note: The Risk analysis should be performed by using the table B.1 in IEC/TR
80002-1.

The risk analysis report will summarize whether identified and mitigated risks meet
the acceptable values defined in this plan. It will also include a statement indicating
whether all known hazards have been identified.

The Risk Management File gathers this document and all documents quoted above.

6. Background
Describe about product.

7. References

7.1. Internal References

# Document Identifier Document Title

1 EVE_QL_SOP001 SOP- Document Control
2 EVE_QL_DCSOP001 SOP - Design Control

 EVELABS TECHNOLOGIES PVT LTD Risk Management Plan | Number RMP001
Version 0.1
Status - Draft

7.2. Standard and Regulatory References

Sl No. Document Identifier Document Title

Quality management systems Requirements for

1 EN ISO 13485:2016 regulatory purposes
2 EN ISO 14971:2012 Application of risk management to medical devices

3 ISO 11607 Packaging Validation

4 IEC 62366 Usability Requirements

5 IEC 60601-1 Basic Safety and Essential Performance

6 IEC 60601-1-2 Electromagnetic Compliance

7 IEC 62304 Software Lifecycle Process for Medical Devices

General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical
8 IEC 60601-1-8 electrical systems.

9 IEC 60950 IT Equipment General Requirements

Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare
10 IEC 60601-1-11 environment

8. Risk Management Plan

The risk management activities coincide with the product development and design control
process (refer Design & Development Procedure and Risk Management Procedure).

Project Phase Risk Management Deliverables

Planning Risk Management Plan

Design and Development 1. System Risk Analysis (hazard

 EVELABS TECHNOLOGIES PVT LTD Risk Management Plan | Number RMP001
Version 0.1
Status - Draft

identification
2. System Risk evaluation
3. Risk Assessment

Design Verification 1. Risk Control

2. Residual Risk Acceptance

Design Validation 1. Risk Management Report

Design Transfer/Market Release 1. Production and post production risk

management
2. Revised risk management report

Table 1 - Risk Management Deliverables by Project Phase

Risk management deliverables are reviewed and approved during design reviews for each
project phase. ISO 14971:2007 and/or EN 14971:2012 shall be used for instructions and as
guidelines during risk management documentation. Refer to Risk Management Procedure
for the company process.

Risk is defined as the combination of occurrence of harm and the severity of that harm. In
order to estimate risks of hazardous situations relating to Class B device, severity of harm
and probability of occurrence of harm are estimated according to the tables below.

Severity Rating Description

Critical Loss of life or Life threatening injury

Major Severe, long-term injury; potential disability

Short-term injury or impairment requiring

Serious additional medical intervention to correct (e.g.
reoperation)

Minor Slight customer inconvenience; little to no effect

on product performance, non-vital fault

Negligible No or no risk to patient

Table 2 - Severity Table

Probability Rating Description

Frequent 1 in 100

Probable 1 in 1000

Occasional 1 in 10000

Remote 1 in 100000

Improbable 1 in 1000000
Table 3 - Probability Tables
 EVELABS TECHNOLOGIES PVT LTD Risk Management Plan | Number RMP001
Version 0.1
Status - Draft

Risk level is determined based on probability and severity estimates.

Frequent Low Medium High High High

Probable Low Medium Medium High High

Occasional Low Low Medium Medium High

Remote Low Low Low Medium High

Improbable Low Low Low Low Medium

Negligible Minor Serious Major Critical

Table 4 - Risk Estimation

9. Criteria for acceptability

Risks for DRIPO is identified as LOW, MEDIUM and HIGH
Risks in the LOW shall be acceptable and no recommended actions are required
Risks in the MEDIUM shall be acceptable, Some risk control actions may be used,
where possible, to lower the level.
Risks in the HIGH is unacceptable and require risk reduction.