Compliant Software Development
Medical device software development is not a trivial thing. You have to develop software in line with its intended use and compliant with ISO 13485 and IEC 62304 standards –just to name a few of them. If you add GDPR and 21 CFR 820 to this equation, you can get easily lost. Work with Pro4People, a medical device software development partner that knows this domain inside out.
By choosing Pro4People you’re ensuring:
- a partner with in-depth knowledge of medical device software development
- IEC 62304-compliant software development process
- meeting ISO 13485, ISO 14971, IEC 62366 requirements applicable to software development
- high quality of the delivered product
- the completion of both research and maintenance phases addressed
- minimized medical device regulatory risk owing to a trustworthy partner
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 defining and coordinating the certification of ISO 13495 quality management systems. Use our well-defined, evaluated and proven IEC 62304-compliant software development process. All of that neatly defined 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.
Medical Device Software Development Inputs
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
- Medical software context diagram (one of the architecture views)
- System requirements (software and hardware)
That input will be then used to understand the regulatory context of the new development project.
IEC 62304 Process Tailoring
The goal of this step is to agree upon processes and procedures to be used in software development. The documentation index document is created that describes if Pro4People’s or the Client’s processes, procedures, document templates will be used for developing biotech software. Part of the process tailoring activity is the agreement on tools and their required qualification records. Pro4People will propose the development process to be adopted and agree, at the frequency of milestones that will be used by Client, to control both the development progress and ISO 13485 process compliance. All of the above decisions will to the input you provided.
IEC 62304 Software Development Process
Pro4People has defined and managed the IEC 62304-compliant software development process. That greatly simplifies the collaboration as well as minimizes the time required to develop medical device products. Pro4People provides the development team that manages all the complexities of IEC 62304 development. You will work with fully manned team with all the roles available, just to mention:
- Project Manager
- Business Analyst
- UI/UX Designers
- Software Developer
- Quality Assurance
- Configuration Manager
The use of the iterative software development lifecycle enables your organization to have control over the functionality of the developed solution. The Project Milestone Review meeting held quarterly allows your Regulatory Team to make sure that all the expected deliverables and records are in place. This way when you bring your medical device to market the regulatory risk is brought to minimum.
ISO 13485 Software Verification and Validation
Part of the medical software development process 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 certification trainings. As the project continues, the test design and development result in the continuous development of test documentation. On the defined project milestones, tests are executed and the quality and the completeness of the release is evaluated. Validation can be started as soon as all the records, traceability and final quality software assessment have been delivered together with the release to the client in accordance with ISO 13485 requirements.