From the high-level regulatory strategy, we further breakdown the various milestones into actionable items and ensure that your development team understands the importance of overcoming these hurdles.

User needs and product requirements (Design Inputs)

Identification of user needs is essential to kickstart the medical device design and development (D&D) phase. Usability engineering has also now been made mandatory as part of the D&D process. Including other essential information such as regulatory directives, guidances, product standards and risk management considerations, these are translated into product requirements (Design Inputs). 

Design Outputs

The product specifications, 2D/3D drawings, datasheets, bill of materials (BOM) are some of common documents that are created during this stage. These are outputs translated from the product requirements (Design Inputs). These documents hold key information about the medical device design and forms part of the Device Master Record (DMR). The DMR is the file that includes all information to your product design and manufacturing specifications.  

Design Verification & Validation

During the verification stage, we work with your internal team and external testing houses to ensure the design outputs meets the product requirements via a slate of tests performed. This includes analytical, software, electrical safety, packaging, labelling, biocompatibility, sterility and any other pre-clinical testing related to your medical device. 

In the design validation stage, the main objective is to ensure that the design outputs meet the user needs of your medical device. Some medical devices can leverage on clinical data from literature review and/or products with similar intended use to demonstrate this. If such information is unavailable, clinical trials should be conducted to demonstrate safety and effectiveness of your medical device. At Yeng & Leong, we worked with our contract research organisation (CRO) partners to manage your clinical trials, which includes protocol writing, monitoring, data management, biostatistics and other compliances. We ensure that your trials are performed in good hands.