We cover the full MDSW lifecycle to support you with all Regulatory and Quality challenges.
In today’s world, medical device companies are aiming to fulfill the unmet needs of patients and health care providers by leveraging the latest technological advancements and by making use of the vast increasing digitization.
Software takes an important role both in and around medical devices. Devices are “connected” thanks to the emerge of IoT (Internet Of Things) and its accompanying parts (smartphones, wearables, cloud-servers, cheaper and better sensor technology, big data, and AI). Covid pandemic further accelerated this trend and necessitated remote healthcare services.
Medical device companies must divide their attention among a broad variety of tasks. Not only do the technical and innovative aspects of their product require their attention, but also the regulatory and quality aspects are challenging and, in some cases, underestimated.
Under the new EU Medical Device regulations, i.e., regulations 2017/745 (MDR) that is applicable since 26 May 2021 and regulation 2017/746 (IVDR) that will be applicable as of 16 May 2022, risk classification of the Medical Device Software (MDSW) is relatively complex and most often results in a higher risk class compared to the old Medical Device Directives.
This results in specific regulatory requirements. In addition, medical device manufacturers are expected to follow industry standards and guidelines applicable on MDSW (e.g., ISO13485, ISO 14971, IEC 62304, IEC 82304, …)
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