AMDD’s development services are ISO 13484:2016 compliant for design, design remediation, verification and validation. AMDD Risk Analysis processes are ISO 14971: 2016 compliant and provides risk analysis at each phase of development lifecycle.
See Our Services
MEDICAL DEVICE DESIGN AND DEVELOPMENT
AMDD’s multidisciplinary engineering group are continuously trained and kept abreast of improved techniques, technological advances in the industry and the best engineering tools available. Averaging more than a dozen years of experience each in the medical device design and development arena. Our experts are adept at developing medical devices integrating state of the art technologies, tools, procedures and practices while focusing on customer satisfaction.
DHF REMEDIATION/PRODUCT LIFECYCLE MANAGEMENT
The Remediation services encompasses all aspects of the medical device product lifecycle: The Design History Files, Device Master Records, Regulatory Compliance, Process Validation and Verification, Requirements Management, Verification, Validation, Design reviews, Requirements Tracing of your products and services. AMDD ensures that the product we partner with you stays in compliance with the ever-evolving FDA and ISO needs..
AMDD helps in delivering the best and latest in product development practices and safeguards to enhance the operational efficiencies, collaboration and management through agile methodologies in all engineering disciplines.
HUMAN FACTORS ENGINEERING
AMDD Human Factors Engineering and User Engineering (HFE/UE) follows IEC60601-1 processes to design and document the human factors in the Usability Engineering File. Hazards and Risks associated with HFE/UE are captured in a User FMEA per ISO 13485:2016. AMDD designs and develops equipment, devices and processes to optimize human –medical device interaction.
AMDD utilizes Agile methodologies to prototype quickly and test with end users to mitigate product and project risk. By leveraging our design processes we save time money and product failures with early testing and increased innovation.