Agile Medical Device Design
Bringing Medical Devices to Life
OUR DESIGN AND
ENGINEERING SERVICES
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
SOFTWARE ENGINEERING
Structured software development for medical devices, ISO 62304 compliance
ELECTRICAL ENGINEERING
Advanced electrical engineering and for both medical and consumer products
MECHANICAL ENGINEERING
Robust mechanical engineering, concept development, trouble shooting manufacturing processes and everything in between
PRODUCT LIFE CYCLE MANAGEMENT
Medical Device Remediation, DHF gap remediation, V&V testing, obsolescence design
VALUE-ADDED CONSULTING
Market analysis, IP management, QMS integration, regulatory strategies, management consulting
Clients We’ve Served
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.
Our Portfolio
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.
OUR CUSTOMERS ARE OUR PARTNERS
When Agile Medical Device Design partners with you we become vested in your success. Our agile ethos spills into out business culture, and we strive to create a synergy with our partners.
ISO 13485:2016 COMPLIANT QUALITY SYSTEM
When Agile Medical Device Design partners with you we become vested in your success. Our agile ethos spills into out business culture, and we strive to create a synergy with our partners