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ACMD Engine is a project management and implementation process to accelerate planning, development and translation of medical devices and healthcare technologies.
This program assists in establishing and managing research and development activities using a stage-gated approach and is aligned with local and international regulatory requirements.
define product requirements documentation and risk analysis
capture validation and verification planning
initiate bench testing and pre-clinical study programs
consideration for biocompatibility, manufacturability and final product presentation
develop tech files and quality docs for regulatory application
connect with ISO 13485 suppliers and manufacturers