Bayoonet - Requirements Management Medical Software
From Medical Software
Software development in the field of medical technology products is caught between individual customer requirements and strict legal regulations. Agile requirements management is needed to meet both conditions.
Keeping an eye on the constantly changing, customer-specific requirements and specifications in accordance with the IEC 62304 standard is the challenge for our requirements engineers. This is because the complete documentation of software requirements according to IEC 62304 and QSR (in the USA) is also required by law.
We accompany you from the very beginning and define the product requirements together with all stakeholders and user groups. These are then further specified by our cross-functional teams of requirements engineers, software architects, verification experts and subject matter experts. The resulting system and software requirements provide the ideal starting point for standard-compliant development of the product.
We know where problems can arise
Requirement for finding solutions
Goals and requirements