ISO 13485 requires that organizations establish documented procedures for the validation of the computer software used in production. The intended application of computer software in monitoring and measuring devices must be confirmed before initial use.
IEC/ISO 62304 is the international standard for medical device software according to the software life-cycle process model. This standard covers software development & maintenance, risk management according to ISO 14971, partitioning and safety classification of software items, and software process management.
GEMARMED has the regulatory and technical expertise to help you implement and meet the requirements of these standards, which are recognized by FDA and other international bodies.