ACMD Engine provides project management and advice towards accelerating activity by initiating planning, product development and translation of MedTech.
This program the Project Development Pathway. Supporting our Partners through the delivery and execution of ACMD-Projects. 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
