Compliant Software Development
Developing IEC 62304 compliant software for medical devices is not a trivial thing. You have to develop software in line with its intended use and compliant with ISO 13485, ISO 14971, and IEC 62304 standards. If you add GDPR and 21 CFR 820 to this equation, you can get easily lost. Work with Pro4People, a IEC 62304 software development partner that knows this domain inside out.
By choosing Pro4People you’re ensuring:
- a partner with in-depth knowledge of medical device product lifecycle
- IEC 62304 compliant software development process
- meeting ISO 13485, ISO 14971, IEC 62366 requirements applicable to software development
- instant progress thanks to available templates and working standards about SDLC
- high quality of the delivered product
- minimized medical device regulatory risk
Our Experience with ISO 13485 / IEC 62304
Work with a medical device software development partner that understands medical device regulations. Our employees participated in the development of medical devices up to Class IIb and B software safety classification. We have taken part in implementation and coordinating the certification of ISO 13485 quality management systems. Use our well-defined, evaluated and proven IEC 62304 compliant software development life cycle (SDLC). All of that neatly available and internalized in the organization thanks to ins2outs – a quality management system.
You have no idea what we are talking about? Please refer to our Business Consulting services to bring that know-how into your organization as well.
When we start working on a medical device project, there is certain scope of information that will be required for tailoring IEC 62304 compliant software development process. The input would consist of:
- Medical device intended use
- Medical device classification
- Medical device regulatory strategy
- Product requirements
That input will be then used to understand the regulatory context of the new development project.
The goal of this phase is to agree upon what is to be developed in Software Development phase of SDLC. We will create initial plans like Software Development Plan, Configuration Management Plan and Test Strategy. The scope of deliverables will be finalized in the Documentation Index. Also, the initial alignment between Quality Management Systems is usually introduced at this moment. When the Product Requirements are turned into Software Requirements we are ready for the Design Start milestone review and incoming Software Development phase.
IEC 62304 Software Development Life Cycle (SDLC)
Pro4People has defined and managed the IEC 62304 compliant software development life cycle. It greatly simplifies the collaboration as well as minimizes the time required to develop medical device products. Pro4People provides the project team that manages all the complexities of IEC 62304 SDLC. You will work with fully manned team with all the roles available, just to mention:
- Project Manager
- Business Analyst
- UI/UX Designers
- Technical Leader
- Software Developer
- Quality Assurance
- Configuration Manager/DevOps
The use of the &iterative software development life cycle enables your organization to have better control over the incoming releases. Regularly planned project milestones allow your Product Team to make sure that development is continued as planned and that all design outputs are in place.
ISO 13485 Software Verification and Validation
Part of the medical software development life cycle is validation and verification. Pro4People defined the Quality Assurance processes derived from ISO 29119 and ISTQB best practices. All our personnel have adequate competencies confirmed with ISTQB certifications and trainings. As the software development life cycle continues, tests are designed and implemented. On the defined project milestones, tests are executed and the quality and the completeness of the release is evaluated. All the required records are delivered as Design Outcomes.
When a new software Release Package has been verified with SDLC, a new set of deliverables is prepared for design transfer. These deliverables are transferred, in a secure manner, to the team responsible for Solution Providing product phase. The set would usually consist of:
- Release Package
- Release Notes
- Test Plan, Test Levels Specifications, Tests Execution Summary Report
- Manuals for installation, deployments, and operations activities
- Documentation and records as specified in the Documentation Index
That Design Outputs will be then used by the Solution Providing team to plan for reviews, transition and validation activities.
Neil Daly - CEO of Skin Analytics
“We selected Pro4People as a strategic development partner based on their deep understanding of delivering Software as a Medical (SaMD) products. They’ve been engaged, collaborative and an extremely valuable partner. “
CEO of Skin Analytics