With the Regulation (EU) 2017/745 – MDR and the Regulation (EU) 2017/746 - IVDR, manufacturers of Medical Device Software face ever increasing challenges regarding safety and security. The two main pillars to fulfil the general safety and performance requirements related to software as outlined in Annex I of the MDR and IVDR are to implement conformed software lifecycle and cybersecurity processes. We help you in establishing the lifecycle processes of your Medical Device Software according to IEC 62304 ranging from software development planning, requirements specification, creating and optimizing software architecture, planning and implementing the verification strategies, and the documentation of the whole activities. For standalone software, the validation aspect according to IEC 82304 will also be considered.
We also help you in implementing the best practice of industry standard for cybersecurity under the consideration of the medical device regulatory framework, e.g. the MDCG 2019-16 Guidance on Cybersecurity for medical devices, FDA Guidances for cybersecurity for medical devices. Together with establishing the software lifecycle processes, we help you in performing threat/risk management, secure design, strategic planning for security testing, and the documentation of all activities in the lifecycle processes. Through our active collaboration in the standardisation committee for medical device software and information security for medical device, we can provide you the solid approach and solution to ensure the compliance of your Medical Device Software.