Enormous demands are made on products that operate in the medical technology field: systems are increasing in complexity, innovation cycles are getting shorter and regulatory requirements continue to grow. This burgeoning pressure is associated with major requirements in terms of innovative strength and the readiness of R&D and IT development organisations to undergo change. R&D and IT organisations can meet the challenges associated with this fast pace of change by systematically streamlining their development and production processes, as well as initiating efficiency improvement projects and using repeatable models.
Higher regulatory conformity – improvement in business value
We will show you the resources and methods you can use to investigate your development and production processes and make them run more efficiently. In the areas of systematisation of requirements engineering, system architecture, verification and validation, traceability management, change management and configuration management, we can help to verify your optimisation potential. Moreover, we will show you how to bolster your innovative strength, build cost-effective, high-quality software faster and simultaneously fulfil the applicable regulatory requirements.
We will work with you to develop systems and procedural models and provide support during their successful introduction in your organisation. Our services combine superior professional competence with well-founded sector-specific expertise – not to mention an appreciation of the challenges faced by R&D and IT organisations in the field of medical technology, as well as the concerns of their employees.