Atego experts have extensive skills in developing software that integrates with custom hardware in all stages of the medical product life cycle development. Our customer projects range in size from small components of a larger project to complete full turnkey medical software development and integration. Atego have helped customers get to market quicker and achieve FDA approval successfully, ensuring your project is on schedule, within budget and achieves successful certification.
Atego products and expertise are sought for medical applications because they are proven to be safe, reliable, and effective, while being more cost effective than competing approaches. Whether projects are looking to automate your critical review process within your systems and software engineering lifecycles, process authoring, management and deployment or modeling technologies. Atego provides solutions that give Atego customers a powerful competitive edge, with lower costs and faster time to market, while also supporting the highest levels of safe operation.
Regulatory bodies involved in the approval of medical devices and instrumentation require ever more rigorous audit processes to be followed which results in all software systems being designed, rather than simply evolving. Companies like DCA Design International, Elekta Oncology Systems, Oridion Medical Systems and IIP Technologies use Atego to develop medical devices including drug delivery and diagnostic devices, insulin pump systems, IMRT oncology equipment monitoring and control systems, patient monitoring products and cardiovascular therapeutic devices.
By embracing the latest OMG SysML and UML standards to build and deploy components across projects and platforms, Atego Modeler is used by developers to model their requirements and their complex medical systems together, linking them to ensure that specific components can be demonstrated to meet requirements at the modeling level, before continuing to software development and coding. They also use Atego Modeler’s automatic code generation, targeting their specific programming language demands for Ada, C, Java, C++and C#, significantly improving developer productivity.
Atego Process Director is a ground breaking process authoring, management and deployment technology, based on Atego’s vast experience in process improvement, on real life projects. This is the ideal authoring and rollout tool for your medical systems design and development processes.
Atego Check automates the critical review process within your systems and software engineering lifecycles. It responds to changes in files, web pages, configuration management artifacts, as well as emails, QR codes, scheduled events. Tasks are then allocated to your reviewers and associated with specific Checklists from your own best practices or can utilise the preloaded Atego Checklist libraries. Full review and audit facilities are also provided within this lightweight, web based tool to give you everything you need to manage and track your reviews and checklists.
Atego’s Global Services organization bridges the gap between your company’s existing expertise and core competencies and the special and perhaps temporary needs that you might have for your next important medical systems project. Atego offers strong knowledge of real-time and critical systems, indeed the relevance and success of Atego Global Services come from our experience in developing software for customers with high expectations to meet their deadlines, fulfil commitments and deliver quality services. Atego Global Services comply with the FDA’s 510(k) and PMA requirements and compliant with both the FDA’s 21 CFR Part 820, and the ISO/DIS 13485 standards for quality systems.
Atego’s solutions maximize benefits and provide the best industry practices with lower costs and faster time to market, while also supporting the highest levels of safety certification.
The following training courses are available:
- An Introduction to SysML and MBRE
- Model-based Requirements Engineering
- SysML Modeling with Artisan Studio
- Using Atego Process Director
The following associated articles and white papers are available:
- FDA 510(k): Medical Device Software Approval
- The New 510(k) Paradigm
- Embedded Software Development
- The OMG Systems Modeling Language (SysML)
- The SysML Modeling Language