Hi friends!!!

In our previous blogs, we have discussed about the following topics.

In today’s blog, we are going to discuss about IEC 62304.

IEC 62304 states the requirements for Medical Device Software. Satisfying the requirements of IEC 62304 is an important task in order to ensure the safety of patients and efficacy of software used in treating the patients.

Therefore, it is important for Medical Device QA/RA Professionals to understand about Software Architectural & Detailed Design requirements as per Clause 5.3 & 5.4 of IEC 62304.

Let’s get into the topic with an overview of few important definitions for better understanding of this blog.

A Software can be decomposed into three categories: Software System, Software Items, Software Units. The top level is Software system and the bottom level which cannot be further decomposed is called Software Units. A Software System can be composed of one or more Software Items, a Software Item can be composed of one or more Software Units or decomposable Software Items.

Software System:

Software System means an integrated collection of Software Items which are organized to accomplish a specific function or set of functions in a medical device software.

Software Item:

Software Item means an identifiable part of a computer program. E.g., Source code.

Software Unit:

Software Unit means a Software Item which cannot be subdivided into other Software Items.

ARCHITECTURE

The Architecture means an organizational structure of a system or component.

SOFTWARE ARCHITECTURAL DESIGN

Transform software requirements into an architecture:

The Manufacturer of Medical Device Software shall transform the requirements of the medical device software identified in the Software Requirement Analysis into a documented architecture.

The architecture describes the medical device software’s structure and identifies the software items. This requirement is applicable for Class B & C, medical device software.

Architecture for the interfaces of software items:

The Architecture which provides details about the interfaces between multiple software items, as well as between the software items and the components external to the software items shall be developed and documented by the Manufacturer of Medical Device Software. This requirement is applicable for Class B & C, medical device software.

Functional & Performance requirements of SOUP Item:

The Functional & Performance requirements of Software of Unknown Provenance (SOUP) Items required for its intended use shall be specified by the Manufacturer of Medical Device Software, if a particular Software Item is identified as a SOUP. This requirement is applicable for Class B & C, medical device software.

System Hardware & Software required by the SOUP Item:

The System Hardware & Software required for proper functioning of the Software of Unknown Provenance (SOUP) Items shall be specified by the Manufacturer of Medical Device Software, if a particular Software Item is identified as a SOUP. This requirement is applicable for Class B & C, medical device software.

Segregation necessary for risk control:

Any segregation between the software items which are required for adequate risk control shall be identified by the Manufacturer of Medical Device Software. The Manufacturer shall also state the necessary steps to ensure the effectiveness of such segregation. This requirement is applicable for Class C, medical device software.

Verification of Software Architecture:

The Manufacturer of Medical Device Software shall verify and document the Software Architecture with respect to the above-mentioned requirements. This requirement is applicable for Class B & C, medical device software.

SOFTWARE DETAILED DESIGN

Subdivide Software into Software Units:

The Manufacturer of Medical Device Software shall subdivide the software until it is represented as Software Units which cannot be further subdivided into Software Items. This requirement is applicable for Class B & C, medical device software.

Detail Design of each Software Units:

The Detailed Design needed for the correct implementation of each Software Units shall be documented by the Manufacturer of the Medical Device Software. This requirement is applicable for Class C, medical device software.

Detail Design for Interfaces of Software Units:

The Detail Design for any interfaces between the Software Units and the external components, as well as between Software Units shall be documented by the Manufacturer of Medical Device Software. This requirement is applicable for Class C, medical device software.

Verification of Detailed Design:

The Manufacturer of Medical Device Software shall verify and document the Software Detailed Design with respect to the above-mentioned requirements. This requirement is applicable for Class C, medical device software.

Now I hope you have acquired some basic knowledge about Software Architectural & Detailed Design Requirements as per Clause 5.3 & 5.4 of IEC 62304. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.

NOTE: Dear friends!!!… Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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