The Medical Device Software Specialists
Healthcare and medical devices software and systems specialists with deep understanding of software development and international regulation and standards. Key skills in software development, safety risk management and software security with experience ranging from low cost embedded solutions to complex systems running on multi-core parallel processors.
Wide experience in healthcare sectors including oncology, proton therapy, imaging, implantable devices, renal therapy, diabetes management, vascular therapy, minimally invasive surgical devices, pressure area care, point-of-care diagnostics and drug delivery.
Approved EU Notified Body Assessor for Software Submissions
- Safety Critical Systems
- Software Development Lifecycle Management
- Application of Agile Methodologies
- Project Management
Medical Device Development:
- Full life-cycle development, ISO13485, MDD, 21 CFR part 820
- IEC60601, IEC62304, ISO14971, IEC62366
- Life-cycle and process development (IEC62304, ISO14971)
- Requirements management, architectural design, detailed design and implementation
- Risk management in software
- Validation and verification