We can rely on long device development experience in electrical medical devices, including embedded software, implants, and instruments for medical device classes Ir, IIa, IIb, and III (MDR). Our knowledge includes new product development of innovative implants, instruments and electrical medical devices and the further development of existing medical products. Furthermore, we supported manufacturers in remediation projects for meeting new regulatory requirements.
To develop innovative products, we can support you with a smart methodology to identify the user needs, generate the corresponding stakeholder requirements and transfer them into the system requirement specification. Stakeholder requirements define product performances needed for the positive benefit-risk ratio, also known as clinical claims and performance. In the context of the product development, verification, and validation activities, stakeholder requirements will be validated, and the system requirements will be verified.
The traceability of such stakeholder and system requirements and corresponding verification and validation allows you to use existing products, components, or features as units or black boxes for new developments. This method is predestined to create a fault tree and thus show the fault progression for systems and allows to use of the units in other systems or product sets. The post-market performance data or vigilance data can be used in different systems on the unit level to describe the probability of failure occurrence. Determining the unit’s reliability during the development and determining the unit reliability in use are content of the discipline risk management.
We would love to support you in developing new products or your development methodology and traceability.