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Part-2 Risk Management Plan

Part-2 Risk Management Plan

Referenace: ISO 14971:2019

Part-2 Risk Management Plan
1.       Risk Management Plan

1.1.     The Risk Management Plan outlines the intended use of the device, its classification, and the relevant standards that apply. It also identifies the Risk Management Team and sets out the approach to be taken during the various stages of the product lifecycle, including design, production, and post-production. Additionally, the plan specifies the criteria for determining the acceptability of device risks, as well as the frequency at which risk control measures should be reviewed and verified for their relevance to device performance and safety.

1.2.     Scope:

The Risk Management Report covers all the phases of the product life cycle of the Nebuliser manufactured at Bhargava Consulting Group as per EN ISO 14971:2019.

1.2.1.  Intended Use:

Nebuliser is intended for speedy nebulization of medication for inhalation by nasal or oral route in respiratory disorders.

1.2.2.  Risk Class: 

Class: C

1.2.3.  Applicable Standards

ISO 10993-1,   ISO 14644-1 & 2,  ISO 27427, BS EN 13544-1.

1.2.4.  Device Life Cycle Phase

The risk management analysis covers the entire life cycle of the device, from the product design and development phase to product decommissioning.

Product Description

Shelf Life

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