The design and development of the MDSW includes the verification and validation stage that is critical for its certification. The IEC 62304 guides you thought the MDSW life cycle. However, it is important to consider quality and regulatory requirements from the Medical Device Regulation (EU) 2017/745 – MDR and ISO 13485.
Depending on the software classification according to IEC 62304 (A, B, C), the manufacturer shall document different processes. The following diagram shows the activities and tasks necessary for the safe design and development of MDSW. All the activities described are aligned with the design and development steps described in the ISO 13485.
Another critical topic to consider is the Risk Management process of the MDSW, that shall be performed according to ISO 14971. The manufacturer shall identify software items that could contribute to a hazardous situation identified in the medical device risk analysis activity of ISO 14971. MDSW risks may be mitigated with technological processes defined during the design phase and verified during the verification and validation of the MDSW. The system testing may be performed with more effort to the higher risks of the MDSW.
Manufacturers shall evaluate the potential impact of any changes to the function, intended use, essential design, and manufacturing characteristics on the software’s qualification as MDSW and its classification (including the classification of the combination of the MDSW with another medical device). It is to be noted that a change to or the addition of functionality to a software may lead it to be qualified as MDSW, or a revision of the classification of the MDSW. Similarly, a module that is added to a software might be qualified as a MDSW on its own. When determining the risk class of a combination of a modified MDSW and a medical device, the intended purpose and functionality of that (new) combination must be considered.
For all MDSW, the manufacturer shall ensure safety and performance throughout the lifecycle of the software, through a continuous process of clinical and/or performance evaluation and risk management.
TDV is an expert consultancy company in software validation. We can assess you through the regulatory and quality compliance of your MDSW design and development as well and doing the right verification and validation of the MDSW to get the CE Mark.
For more information on MDSW please contact us.