The following services are available for your medical device software needs
Quality Management Systems
Envision and build efficient and compliant quality management systems for international requirements including FDA 21 CFR, IEC 62304, IEC 82304, ISO 13485, ISO 14971, ISO27001, MDCG, MDD, MDR, and IVDR.
Software Life Cycle Processes
Design and implementation of effective and efficient software life cycle processes for medical device software from premarket submissions to postmarket surveillance, across a variety of software architectures from embedded to Software as a Medical Device (SaMD) and cloud computing.
Start up and optimize Agile fundamentals including: estimation, backlog management, release and sprint planning, metrics (capacity, velocity, burn-down, burn-up, earned value), daily standups, sprint reviews, and retrospectives. Work with organizations and teams to create a best-fit Agile lifecycle from Scrum to Kanban to hybrid models which also transition from, or integrate with, waterfall lifecycles.
Computer Systems Assurance / Validation (CSA / CSV)
Validation and cGMP compliance of computer systems used in medical device and pharmaceutical operations and quality management systems with special emphasis on risk assessment and electronic records compliance.
Implementation of informative, effective, value-added processes for project risk management including semi-quantitative risk analysis and product risk management including Hazard Analysis and FMEA.
Project Managment and Continuous Improvement
Hands-on implementation of leading-edge project management techniques for technologically advanced products integrating software, electrical, mechanical, and scientific disciplines across geographically dispersed teams.
Definition, selection, and implementation of process improvement initiatives in all aspects of software management, development, and test.
Team Coaching and Training
Help teams be more focused and more effective using high value software processes.