Risk Management begins after concept and feasibility studies are completed and Management approves the initiation of a Product Development Project. This SOP applies to all medical devices that are approved for Product Development as well as to the personnel who are responsible for implementing Design Controls for such medical devices. The SOP describes on how to perform a risk management process, it provides guidance on how to identify hazards, estimate severity and probability of occurrence of harm as well as to evaluate the corresponding risk and on how to mitigate these risks. The SOP describes on how to handle the residual risks after risk mitigations was implemented. This includes hazard identification covering design, manufacturing, labeling/package, maintenance and disposal of the medical device.

Regulatory basis, reference documents

• 21 CFR Part 820 – Quality System Regulation, Subpart C – Design Controls, 820.30 Design controls
• ISO 13485:2016: Medical Devices – Quality management systems ¬Requirements for regulatory purposes
• FDA/CDRH – Design Control Guidance for Medical Device Manufacturers, March 11, 1997
• 21 CFR Part 820-Quality system Regulation, Subpart G- Production and Process Controls
• ISO 14971 Medical Devices: Application of Risk Management to Medical Devices

Table of Content

1 Purpose
2 Objective
3 Regulatory basis, reference documents
4 Responsibility and accountability
4.1 Company Management
4.2 Design Review Committee
4.3 Quality Assurance
4.4 Project Leader (PL) / Head of Engineering (HE)
4.5 Function / Area Leaders
5 Related documents
6 Definitions
7 Procedure
7.1 General
7.2 Risk Mitigation Priorities (general rules)
7.3 Software Risk Analysis
7.4 Risk Analysis File
7.5 Risk Analysis Plan
7.6 Risk Analysis Process
7.7 Functional Analysis (Grey Box)
7.8 Identification of hazards and estimation of risk
7.9 Probability of Occurrence
7.10 Risk Estimation
7.11 Risk Control
7.12 Residual Risk evaluation and Risk benefit Analysis
7.13 Risk Analysis Report
7.14 Post-Production Activities
8 Attachments
Attachment 1: TOC: Risk Analysis Report (1 pages)
Attachment 2: Schematic representation of the Risk Management principle – ISO 14971 (1 page)
Attachment 3: Generic Risk Management graph (1 page)
Attachment 4: Practical Example Risk Management graph (1 page)
9 SOP distribution
10 Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 19 pages procedure

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