Information For International Medical Device Companies

ADM Tronics Unlimited, Inc. specializes in United States Food and Drug Administration
(“FDA”) Medical Device regulatory requirements – from the conceptual design phase through
full production, post-market surveillance and support. It is an FDA-Registered Medical Device
Manufacturing Facility with both Contract Manufacturer and Original Equipment Manufacturer
(“OEM”) registrations. ADM Tronics is a one-stop source for complete electronics design and
engineering services, specifically related to medical electronics – from concept to full production
in its own fully-equipped facility in Northvale, NJ USA.

ADM Tronics provides international clients and partners with an experienced and fully
staffed, US-based FDA-Registered facility. Therefore, ADM Tronics’ clients can more readily
secure FDA and other regulatory clearances to allow non-US medical devices to be quickly and
more efficiently marketed in the US. This accelerates and simplifies the regulatory process in
securing FDA clearance and continued registration. In addition, ADM Tronics provides its
clients with a complete engineering resource for electronics design and production needs with an
experienced, on-staff, multi-disciplinary team of engineers, scientists and technicians.

ADM Tronics has extensive regulatory experience for FDA, GMP, CE, CMDCAS, ETL,
UL, ISO-13485 and other standards and regulations for electronic medical devices. It has been
taking products through the regulatory process since before FDA’s device regulations were
adopted in 1976. And, when required, ADM Tronics can provide clients with a complete,
turnkey documentation and quality system necessary for FDA and other regulatory requirements.
In addition to regulatory and development work carried out for clients and partners, ADM
Tronics has conceived, designed and produced therapeutic and diagnostic electronic medical
devices for its own account, in fields as diverse as audiology, physical medicine, wound therapy
and urology.

With extensive medical device experience and an on-staff multi-disciplinary team of
engineers, regulatory experts and technologists, ADM Tronics has significant internal
efficiencies allowing it to be extremely cost competitive for a US-based, medical electronics
design and manufacturing resource.

If you are seeking the best route to get your electronic medical device onto
the US market, contact ADM Tronics today.