Agile Medical Device Design
We leverage decades of experience in understanding end user need, reimbursement strategies, third party payers, advancements in technology and proven quality processes to bring your medical device to market on time and within budget. We have an understanding of what we need to do to get that medical device into the hands of the people that would benefit from it. What can we do to help you?
Bringing Medical Devices to Life
Our Design and
AMDD’s development services are ISO 13485:2016 compliant for design, design remediation, verification and validation. AMDD Risk Analysis processes are ISO 14971:2012 compliant and provide risk analysis at each phase of the development lifecycle.
Human Factors Engineering
Human Factors Engineering, Usability Engineering (HFE/UE) report per FDA Guidelines
Our success spans a wide range of medical devices, from Class I low risk devices to Class III life support products. We are your partner because of our expertise with the entire design cycle and product lifecycle; from concept to market to product monitoring.
the agile design process
Most medical device manufacturers utilize a classic water fall development process. This is a risk –averse, top down approach that does not keep pace with demands of today’s market place.