PRODUCT DESIGN & DEVELOPMENT
- Medical Product Design in the Medical Device Life-Cycle is a crucial phase to ensure the safety and efficacy of the product.
- Anzil Meditech can support you to train and write verifiable, clear, and concise, traceable requirements, and conduct requirements management at the system level, subsystem level, and component level by understanding your medical device thoroughly. For this, Anzil has an experienced team in the medical device industry.
- Anzil follows the standard requirement-based approach to prepare the Design History File (DHF), which ensures the completeness of documents. Our team has extensive experience in developing the Design Document as per US FDA 21 CFR 820.30 and ISO 13485:2016 for all classes of the Medical device.
- Design control is a set of procedures and practices applied to the design activity intended to ensure that the output product meets the input requirements. It includes understanding user needs, requirements, and thereafter design medical devices to meet those requirements along with risk analysis. Control also includes evaluation of the medical device and transferring it to the production line for manufacturing.
- Anzil can further support you in preparing a complete Design History File (DHF) or Technical File starting from understanding user needs, requirements writing, requirements management, verifying, and validating user needs until design transfer.
- At Anzil, our team has successfully completed and worked with various client teams to support in developing the Design and Development Plan, Design Verification, Validation Protocol and Reports, Design Transfer Plan, and other related documents to complete your design control document.