Over many years of project experience in the life sciences and medical devices with their high regulatory requirements, we have gathered a wealth of knowledge and established effective processes.
We can provide support for all products to ensure sustainability and security throughout the software lifecycle from development, commissioning, operation, change management and maintenance to decommissioning.
We are happy to advise you on project management and compliance with regulations.
Quality management (ISO 13485), risk management (ISO 14971) and software development (ISO 62304) and many pending standards are required of you as a manufacturer. We are happy to support you in this demanding process and documentation.