Design and development (D&D) activities remain the core of most businesses. No matter if you are developing a hardware, software (we understand agile) or a combination of both, Stendard is your preferred regulatory partner. We can develop your D&D Plan together with your team, which consists of the following:
User Needs and Product Requirements (Design Inputs)
Identification of user needs is essential to kickstart the medical device 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 requirements, guidance documents, product standards and risk management considerations, these are translated into product requirements (Design Inputs).
The product specifications, drawings, datasheets, bill of materials (BOM) are some of the documents that are created during this stage. These are outputs translated from the product requirements (Design Inputs) in an iterative process that needs to be clearly documented. Here, we have our technology to help you track this process intuitively, while maintaining the necessary documentation trail for your audits.
These documents hold key information about the medical device design and forms part of the Medical Device File or Device Master Record (DMR). This file includes all information to your product design and manufacturing specifications.
Design Verification & Validation
During the design verification stage, we work with your team to develop a plan that includes a series of tests (with defined acceptance criteria) to be performed. This is often based on the list of harmonised international standards that has been identified in the D&D plan. This includes analytical (CLSI standards), software (IEC 62304), electrical safety (IEC 60101 series, IEC 61010 series), packaging, labelling, biocompatibility, sterility, security 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 existing clinical data from literatures, journals and/or products with similar intended use to demonstrate this. If this is not possible, clinical trials is likely to be conducted, in order to demonstrate the safety and effectiveness of your medical device. At Stendard, 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 conducted in good hands.
Software as a Medical Device
In the world of software, the development and production moves at a fast and iterative pace. Being a software as a medical device (SaMD), design and production traceability is still very much required. We understand your challenges in documenting them manually word documents and excel spreadsheets as design changes happen frequently. With the use of the different software development tools, such as Trello, Jira, Bitbucket, the conventional way of documentation should be obsolete.
At Stendard, we have worked with many software companies before, so let us design together with you a fully traceable process that is an integration of software tools and documentation, while keeping your team agile in the entire software lifecycle.