D2M’s ISO 13485 compliant Quality Management System meets the FDA’s 21 CFR 820 / QSR regulatory requirements for our medical and biotech clients
Our Quality System ensures your device will be produced under strict design controls. In addition, we provide the following options for your path to production.
D2M’s QMS satisfies ISO 13485 requirements and meets the FDA’s Title 21 Part 820 Code of Federal Regulations to ensure the development of safe and effective medical devices.
Our Quality System ensures your device will be produced under strict design controls. In addition, we provide the following options for your path to production.
Risk Management
Identification and analysis of risk throughout the venture per ISO 14971:2007Human Factors Program
User-centered design, adherence to AAMI HE74:2001, and risk mitigation through improved UI and ergonomicsRegulatory Submission Data
A comprehensive design history file for 510(k) / PMA / CE filingPortability to Manufacturing
A design transfer package and seamless manufacturing launchRegulatory Approval Path
Strategic development in compliance with FDA, ISO, AAMI, IEC, UL and other standards
D2M’s QMS satisfies ISO 13485 requirements and meets the FDA’s Title 21 Part 820 Code of Federal Regulations to ensure the development of safe and effective medical devices.