Coalition members are leading stakeholders based in the Western Hemisphere who participate in or actively engage with the medical technology sector, which are incorporated according to the scope of their activities:

Principal Members include industry associations who represent medical technology member companies.

Standardization Members include (1) Standards Developing Organization (SDO), national member body to ISO, IEC or other SDO, or other organization, or technical committee thereof engaged in, or dedicated to, the international standardization of medical devices; (2) any organization engaged in activities pertaining to the conformity assessment of medical devices including the international standardization of medical device conformity assessment criteria.

The Coalition welcomes as observers all affected stakeholders, such as government agencies and regulatory authorities, health care professionals and organizations, that support the Coalition’s mission.

If your organization has interest to join the Coalition, please Contact Us.

REGULATORY COALITION PRINCIPAL MEMBERS