Services
Design & 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.
Medical Device Design & Development
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ELECTRICAL ENGINEERING
Advanced electrical engineering and for both medical and consumer products.
SOFTWARE ENGINEERING
Structured software development for medical devices, ISO 62304 compliance.
MECHANICAL ENGINEERING
Robust mechanical engineering, concept development, trouble shooting manufacturing processes and everything in between.
Algorithm & Simulation Development
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PRODUCT LIFE CYCLE MANAGEMENT
Medical Device Remediation, DHF gap remediation, V&V testing, obsolescence design
Managed Services
- On-site services, both long-term on-site project work and short-term with specific deliverables
- On and off-site project management
VALUE-ADDED CONSULTING
Market analysis, IP management, QMS integration, regulatory strategies, management consulting
HUMAN FACTORS ENGINEERING
Human Factors Engineering, Usability Engineering (HFE/UE) report per FDA Guidelines