Established in 1973, the Association of Medical Diagnostics Manufacturers (AMDM) is a nonprofit trade association that serves as an educational resource for regulatory submissions and other compliance information related to the in vitro diagnostic industry. Our membership includes companies of all sizes who manufacture and distribute in vitro diagnostic products, as well as consultants and other suppliers providing essential materials and services to the industry. AMDM is known for providing educational conferences in which FDA and other regulatory bodies comfortably share information and exchange ideas with industry. AMDM educational conferences are interactive, as well as informative.
"It is the purpose of this organization to raise the standards of excellence, now prevailing, to even higher levels. To attain this goal, we propose the exchange of technical information among members of the industry and mutual
assistance in the formulation of, and compliance with, regulatory legislation standards and protocols."
AMDM Articles of Incorporation, 1973
Purpose
Our Work
Communication with members
We provide members with FDA directives and guidance documents.
We provide information to members on international regulations and guidelines.
We keep members informed of regulatory issues by email as information is received.
We coordinate one to two conferences each year with speakers from industry and the FDA.
Liaison between members and regulatory agencies
We meet with the FDA and other regulatory agencies acting as a liaison for our members.
We take issues common to our members directly to the FDA administration
Professional development
We educate members on compliance issues, manufacturing practices, regulatory issues, and quality issues.
Only AMDM tracks the international legislative initiatives related to the IVD industry.
We provide opportunities for members to network with some of the world's leading authorities.
Our members receive specialized assistance with issues unique to the IVD industry.
Part of the Solution
We work towards FDA reform legislation
We are active in organizations that set guidelines for our industry.
assistance in the formulation of, and compliance with, regulatory legislation standards and protocols."
AMDM Articles of Incorporation, 1973
Purpose
Our Work
Communication with members
We provide members with FDA directives and guidance documents.
We provide information to members on international regulations and guidelines.
We keep members informed of regulatory issues by email as information is received.
We coordinate one to two conferences each year with speakers from industry and the FDA.
Liaison between members and regulatory agencies
We meet with the FDA and other regulatory agencies acting as a liaison for our members.
We take issues common to our members directly to the FDA administration
Professional development
We educate members on compliance issues, manufacturing practices, regulatory issues, and quality issues.
Only AMDM tracks the international legislative initiatives related to the IVD industry.
We provide opportunities for members to network with some of the world's leading authorities.
Our members receive specialized assistance with issues unique to the IVD industry.
Part of the Solution
We work towards FDA reform legislation
We are active in organizations that set guidelines for our industry.
