Medical Equipment and Pharmaceutical Industries

In addition to the challenges confronting teams in development laboratories in other industries, the manufacturers of medical equipment and the pharmaceutical industry are additionally required to comply to the standards of health authorities, in particular the American FDA.

The regulatory compliance (FDA, Quality System Regulation; ISO 13485; CE Mark, EEC 1993) simply adds to the existing pressure to be first-to-market with even more complicated products that need large projects and distributed teams and cost efficiency.

Traceability is one of the key techniques of requirements management that helps companies working in regulated industries to meet regulatory demands as well as general industry challenges.

HOOD supports its customers in these industries with the implementation of requirements management and associated software tools.

Training programmes for both methodology (for example, writing requirements) and tools are just as much part of HOOD’s services as the definition of development processes or establishing agile methods within development teams.

HOOD also provides requirements engineers for directly supporting projects, so that your teams reach their goals more quickly.