IEC 62304:2006 Know-how set
This know-how set defines an IEC 62304:2006, ISO 13485:2016, and ISO 14971:2019 compliant Software Development Life Cycle (SDLC). An organization can use it to develop software in a medical device (SiMD) or software as a medical device (SaMD).
Find out more about the know-how set
Software Development Life Cycle (SDLC) documentation
This know-how set defines a common medical device software life cycle process framework. The framework must be applied by an organization engaged in developing and maintaining software embedded in (SiMD) or constituting (SaMD) a medical device. It includes policies, processes, procedures, instructions, document templates, normative sources, roles, and other content defining the SDLC framework. The know-how set was prepared by experienced software development professionals and rooted in the Software Engineering Body of Knowledge (SWEBOK).
The know-how set documentation was derived from and is linked to the following normative sources: IEC 62304:2006, ISO 13485:2016, 21 CFR 820, ISO 14971:2019, IEC 62366-1:2015, ISO 27001:2022, IEC 82304-1:2016, IEC 82304-2:2021, FDA General Principles of Software Validation. Each normative source has a list of the documentation from this know-how set used to prove compliance. The organization can add its regulations or standards.
The know-how set introduces fundamental roles the SDLC framework requires. The roles define the scope of the training/awareness building concerning the SDLC activities: Project Manager, Business Analyst, Tech Lead, Software Developer, Quality Assurance Engineer (Tester), DevOps, UI/UX Designer, Architect, and others. By assigning a person to a role on ins2outs, you limit their perspective to only essential information. The know-how set uses the ins2outs acceptance tasks functionality to keep training and awareness-building records.
Ready-to-use and structured for software development
The know-how set content is ready to use. It defines the abstractions of the tools used by the SDLC teams like Source Code Repository, Test Management System, Issue Tracking System, etc. This way, the organization can name the tools used in the process without the need to rewrite the documentation. The know-how set also establishes a structure for the SDLC activities in the MD product life cycle. The structure assumes the iterative approach with releases and hotfixes what minimizes the effort needed to recreate the requirement documentation. ins2outs manages the default structure for SDLC documentation and offers appropriate templates.
Know-how set elements
Click on each of the groups to expand and see the complete list
SDLC Elements (80+)
1 - Policies
- SDLC Software Development Life Cycle Policy
14 - Processes
- SDLC Architecture Design Process
- SDLC Business Analysis Process
- SDLC Change Management Process
- SDLC Configuration Management Process
- SDLC Detailed Design Process
- SDLC Documentation Management Process
- SDLC Implementation Process
- SDLC Infrastructure Management Process
- SDLC Project Management Process
- SDLC Release Management Process
- SDLC Software Maintenance Process
- SDLC Tests Design and Implementation Process
- SDLC Tests Execution Process
- SDLC UI/UX Design Process
2 - Procedures
- SDLC Product Release Procedure
- SDLC Software Development Life Cycle Procedure
0 - Instructions
If needed organization can create its own instructions.
51 - Ins/Outs (including Templates)
- SDLC Acceptance Criteria
- SDLC Analysis Outcomes
- SDLC Analysis Outcomes Review Record
- SDLC Baseline
- SDLC Binary Package
- SDLC Change
- SDLC Change Request
- SDLC Configuration Item
- SDLC Configuration Management Plan
- SDLC Detailed Design Outcomes
- SDLC Detailed Design Review Records
- SDLC Documentation Index
- SDLC Environment Installation Manual
- SDLC Environment Installation Requirements
- SDLC Environment Specification
- SDLC External Interfaces
- SDLC IEC62304:2006 Statement of Applicability
- SDLC Infrastructure Qualification Records
- SDLC Issues
- SDLC Legacy Software Gap Analysis
- SDLC Operations Manual
- SDLC Problem Report
- SDLC Product Release Record
- SDLC Product Roadmap
- SDLC Project Operations Management Plan
- SDLC Release Deployment Manual
- SDLC Release Notes
- SDLC Release Package
- SDLC Requirements Review Record
- SDLC Risk Management File
- SDLC Software Development Plan
- SDLC Software Maintenance Plan
- SDLC Software Requirement Template
- SDLC Software Requirements
- SDLC Software Requirements Specification
- SDLC Solution Architecture
- SDLC Solution Architecture Review Record
- SDLC Source Code
- SDLC SOW – Statement of Work
- SDLC Supplementary Project Plans
- SDLC Technology Stack Specification
- SDLC Test Case
- SDLC Test Item
- SDLC Test Level Execution Report
- SDLC Test Level Specification
- SDLC Test Plan
- SDLC Test Strategy
- SDLC Tests Execution Summary Report
- SDLC UI/UX Guidelines
- SDLC User Interface Design
- SDLC User Story
6 - Normative sources
- SDLC IEC62304:2006
- SDLC IEC 62366-1:2015
- SDLC ISO 29119-1:2022
- SDLC ISO 29119-2:2021
- SDLC General Principles of Software Validation
- SDLC IEC 82304-1:2016
8 - Roles
- SDLC Business Analyst
- SDLC DevOps
- SDLC Developer
- SDLC Project Manager
- SDLC Quality Assurance Engineer
- SDLC Solution Architect
- SDLC Technical Leader
- SDLC UI/UX Designer
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Buying the know-how set
To buy a know-how set, you must order it using the contact form below. ins2outs would issue an invoice that covers the one-time payment for the know-how set. After the payment, ins2outs copies the know-how set to the organization’s account on ins2outs. The account must be active and have at least one paying user assigned. From that moment on, the know-how set is available for your organization. It usually takes one hour to copy the know-how set once the payment is confirmed.
Know-how set license
Once purchased, ins2outs grants your organization authorization for non-exclusive use of the Know-how set (non-exclusive license). The license is given in return for a one-time fee for the know-how set for the current status of the set. The license is granted for an indefinite period. The know-how set cannot be resold or made available outside the purchasing organization. The license limitations are documented in the Terms and Conditions document chapter “VI. Know-how set license”.
Ten hours of free consulting
When you purchase this know-how set on ins2outs, you are entitled to ten hours of free consulting. The purpose of that support is to smoother your entry into the ins2outs platform and show how to use ins2outs effectively. The service will be delivered by our SDLC consultants. You define the schedule and the topics for which this consulting can be used. Try our MD Project Manager as a Service (MDPMaaS) offering to prolong that service.
Explore the benefits of starting your system definition with this know-how set
Deliver know-how to your organization in one hour
Acquire the IEC 62304 know-how set instantly from the ins2outs platform. Let your software engineers focus on designing, coding, and deployment, not the process definitions.
Shorten by up to 75% your SDLC implementation time
The SDLC implementation can be a prompt and effective process. Combine ins2outs software, IEC 62304 know-how sets, and tools you used in your software development team to develop medical device class software with the minimum regulatory burden.
Avoid SDLC non-compliance risk
By bringing the IEC 62304 know-how set, you can introduce a new model focused on reliability and medical device software safety. Developing in the undefined SDLC model can result in rejecting your product long after the development is over and you are getting ready for market approval. Bring such risk down by using a reliable SDLC model.
Shorten medical device market approval
It takes excellent coordination of intended purpose definition, product management activities, and managing notified bodies or market regulators to place a medical device on the market promptly. Shorten your path to market with experts.
Explain to engineers medical device specificity
The SDLC described in IEC 62304 is about developing safety critical systems. The current development models are not built for that kind of system. The know-how set, prepared by software developers, explains an SDLC resulting in more reliable and safer-to-use software.