Documentation Support for Compliance - Medical Diagnostic Devices
Axiom's design team has extensive understanding of the compliance regime for Medical Diagnostic Devices. In particular, we know and understand the need for stringent documentation to comply with various standards including FDA CFR 820.30 for Design Controls, ISO 13485 and ISO 14971:2007 for Risk Management.
Axiom can support various documentation needs for customers in this area.
The Axiom team has extensive experience in component sourcing, supplier identification, specifications development and matching and documentation. Many of our engagements involve modernizing an existing design, optimizing the existing BOM, removing or consolidating existing components. Consequently, Axiom has a lot of experience in standardization of components and developing sourcing strategies. In some of our engagements, we provide documentation support for BOM Standardization and Obsolescence management. The key steps include:
Study of the existing BOM in a given Data Management System and review of the specifications of individual components.
Mapping of each of the components into an existing master list and identifying equivalent part numbers,
Creating new part numbers for components that do not already exist in the data management system.
Fill in appropriate data forms for the new BOM as well as new components
Update the data management system with the new BOM
Axiom Consulting is a New Product Development, R&D Services, Innovation, Design, Engineering and Prototype development Company, providing end-to-end solutions across the product lifecycle. We provide customized services in the areas of Mechanical Engineering, Embedded Electronics, Electrical Engineering, Software systems, Special Purpose Machine and Robotics.
