The development of Medical Devices that contain associated software, or similarly the production of software classified as a Medical Device, implies the adherence to validation criteria not only in the fulfillment of the principles defined in 21CFR 820 but also in the application of the quality system and product lifecycle that would be in line with ISO 14385, ISO 62304, ISO 14971 and other applicable certifications.
Our participation in Medical Device projects is centered in the development of the required documentation:
- Risk management during the various stages of development, testing and maintenance of the system.
- Identification of the quality standards to be followed in each stage of the process.
- Functional verification testing.
- Incident management.
- Preparation of the documentation for the CE marking and/or 510(k), whichever is applicable.
Unlike other computerised systems, the requirements for design, testing and the management of risk for Medical Devices implies extra attention. This not only applies to the management of the different stages, but also to the methodology to be followed and always with the need to demonstrate that the Intended Use of the Medical Device is maintained and the supporting evidence proves this to be true.