System architecture definition is the foundation of product design, and is one of the most critical phases of the design process. M&M Consulting can help you identify simple and cost-effective system architectures that will position your design team for success in the detailed design phase, and your company for long-term financial success as a medical device leader.
We are able to provide turnkey detailed component design services, or augment your existing technical capabilities, with experience in design for virtually all common fabrication methods. Large or small, simple or complex, M&M Consulting has the expertise to develop fully-detailed manufacturable components that meet your design requirements.
Tolerance Stack Analysis (TSA) is a critical part of the design process once more than a handful of units will be built. The all-too-common "design for nominal" philosophy can work for prototyping, but inevitably yields disastrous results in a manufacturing environment. A thorough understanding of component tolerances and assembly tolerance stack-ups will ensure that your design is manufacturable and functional for the long haul. Whether you are producing a few hundred units per year, or a few million, M&M Consulting can offer guidance and right-sized templates & analysis methodologies to serve your specific needs.
We get it – risk management can seem overwhelming. We are well-versed in the application of risk management principles to the medical device industry, and can offer training, templates, and ISO 14971-compliant methodologies for risk evaluation and risk management. Let us help you navigate the standards for your specific application.