The service covers review of quality management system documentation and product-specific life-cycle documentation in accordance with the IEC 62304 standard. The basis of assessment is the software life-cycle documentation in accordance with the IEC 62304 standard, building on a quality management system in accordance with ISO 13485.
Initial certification of a product requires review of the quality management system documentation in accordance with the IEC 62304 standard, and assessment of life-cycle documentation of the relevant software product (stand-alone software or embedded software).
Clients can use a change report form to notify the certification body of software changes. Following a change review, the number of the software revision is updated on the certificate. Minor bug fixes that do not result in a change in use or a change in the accompanying documentation need not be reported, and thus should not be identified in the revision number on the certificate.
Recertification of IEC 62304 will be combined with the ISO 13485 recertification in most cases. During recertification of IEC 62304 all relevant changes to the software lifecycle processes will be reviewed as well as all changes to the software which is covered by the IEC 62304 certificate(s).
The validity of an IEC 62304 certificate depends on the validity of the assigned ISO 13485 certificate issued by TÜV SÜD, and is thus set at a maximum of three years.
The TÜV SÜD octagon
As well as holding the certificate, the software manufacturer is authorized to affix the respective TÜV SÜD octagon to its software product. The software manufacturer may use the TÜV SÜD octagon on the product itself and in the product documentation and – in the case of stand-alone software – may integrate the octagon into the on-screen display.