STANDARD OPERATING PROCEDURE

Title: Medical Device Risk Analysis

Effective Date: _________________

Approvals (Signature and Date):

_____________________________ __________________________ ____________________________

Responsible Department Head Technical Authority QA/QC

1. PURPOSE

1.1 To define the procedure for performing, documenting, approving, and archiving a medical device risk
analysis.

2. SCOPE

2.1 All medical devices manufactured and/or distributed by Company that are used in clinical trials or
placed on the market or put into service.

3. RESPONSIBILITY

3.1 Technical authorities (individuals at Company with technical expertise) and persons identified in the
risk management plan are responsible for participating in the Risk Analysis and reviewing the Risk
Analysis Report.

3.2 R&D Project Leaders are responsible for organizing a Risk Analysis at least at the start of the
development process and at the end. They shall also revise the Risk Analysis whenever important
information becomes available.

3.3 R&D Project Leaders are responsible for including the Project Risk Analyses in the Project
documentation.

3.4 Document Control is responsible for including the Product Risk Analysis Report into the Technical
Documentation.

3.5 Document Control will assure that the Product Risk Analysis Report is reviewed on an biannual basis.

4. REFERENCES AND APPLICABLE DOCUMENTS

4.1 Medical Device directive (93/42/EEC).

4.2 12-0050-SOP-1.0, Design Control Guidelines
4.3 12-0059-SOP-1.0, Quality Records Collection and Retention
4.4 ANSI/AAMI/ISO 14971:2000, Application of Risk Management to Medical Devices
4.5 12-0015-SOP-1.0, QVD Protocol and Report Preparation
4.6 09-0199-SOP-1.0, Technical Documentation for CE marked devices.
4.7 12-0065-SOP-1.0, Design Stage Deliverables.
4.8 IEC 60601-1-4, Medical electrical equipment - Part 1-4: General requirements for safety - Collateral
Standard: Programmable electrical medical systems
5. MATERIALS AND EQUIPMENT

5.1 None.

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6. HEALTH AND SAFETY CONSIDERATIONS

6.1 None.

7. DOCUMENTATION REQUIREMENTS

7.1 Risk Management

7.2 Risk Analysis Reports

7.3 General product description

8. DEFINITIONS

8.1 HARM is the physical injury and/or damage to health or property.

8.2 HAZARD is the cause of/source leading to the harm.

8.3 RISK is the probable rate of occurrence of a hazard causing harm and the degree of severity of the
harm. RISK = PROBABILITY OF THE HAZARD AND SEVERITY OF THE HARM.

8.4 SAFETY is defined as the freedom from unacceptable risks.

8.5 RISK ANALYSIS is an INVESTIGATION of available information to identify hazards and to

eliminate risks.

8.6 RISK ASSESSMENT is the EVALUATION of all the risks identified, and is the process by which the
manufacturer decides whether the device is to be considered as safe.

8.7 RISK MANAGEMENT the process by which the manufacturer reduces and CONTROLS the risk on
an ongoing basis.

9. PROCESS - GENERAL

9.1 A Risk Management Plan is written at the end of the Feasibility Stage or at the beginning of the
Development Phase of product development as defined by 12-0050-SOP-1.0. The plan defines the
documentation required for the risk analysis report and the group responsible for reviewing and
approving the risk analysis.

9.2 A Risk Analysis is performed during the Development Stage after the product requirements
definition/specification has been completed. Additional Risk Analyses are performed during the
development process as defined in the Risk Management Plan or when there are significant changes in
the product specifications.

10. PROCESS - DETAILS

10.1 Risk Management Plan:

10.1.1 The project manager should determine who is responsible for writing the risk managment
plan.

10.1.2 The following items are defined and documented in the Risk Management Plan:

10.1.2.1 scope of the risk analysis (identification of device, etc.).

10.1.2.2 the general strategy taken to minimize risk(This may include design changes,
clinical trials, input from experts, etc.)

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 10.1.2.3 the participants and their responsibilities within the risk analysis. A participant
should be chosen from each appropriate technical area as listed below

• Project Leader
• R&D Technical Authority
• Engineering Technical Authority
• Manufacturing Technical Authority
• QA/QC Technical Authority
• Clinical Affairs Technical Authority
• Marketing Technical Authority
• Regulatory USA
• Regulatory Europe
• Other individuals as identified by the participants.

10.1.2.4 the documentation (test reports, standards, etc.) to be reviewed before performing
the risk analysis.

10.1.2.5 the rating criteria for severity and probability.

10.1.2.6 a description of what level of risk is acceptable

10.1.2.7 the documentation required in the risk analysis report.

10.1.2.8 hazard/measurements list(s) selected. These are lists defined in standards or created
for other products used.

10.1.3 Format and Approval of the Risk Management Plan

10.1.3.1 Risk Management Plans are formatted as ENGR documents from Engineering or
Research and Development

10.1.3.2 The only approvals required are the project leader, the technical authority in
Research and Development, and an appropriate member of the clinical research
group.

10.2 The Risk Analysis

10.2.1 Identification of hazards based on the functions and characteristics of the product.

10.2.1.1 A list of functions and characteristics is created based on the Product

Requirements/Specifications Document.

10.2.1.2 Possible hazards are identified for each function and characteristic:

10.2.1.2.1 Possible hazards are identified for normal conditions and (single) fault
conditions.

10.2.1.2.2 The list shall include hazards such as misuse, stability problems, batch
to batch variations, power failure.

10.2.2 Identification of harm:

10.2.2.1 Each hazard results in a specific physical injury and or damage to health or property

10.2.2.2 The specific harm should be identified for each hazard

10.2.3 Identification of risk reduction measures.

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