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’s development services are ISO 13485:2016 compliant for design, design remediation, verification and validation.

AMDD’s 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, troubleshooting 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. Because of our expertise with the entire design cycle and product lifecycle, from concept to market to product monitoring, we make a powerful addition to your team.

Our Portfolio

THE AGILE DESIGN PROCESS

Most medical device manufacturers utilize a classic waterfall 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