Medical Device Regulatory Services | ADM Tronics

201-784-6040

sales@admtronics.com

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Regulatory Services

ADM Tronics is an Experienced and Efficient Regulatory resource.

Medical Device Regulatory Specialization

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.

ADM Tronics operates 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.

Regulatory Expertise

ADM Tronics has extensive regulatory experience for FDA, GMP, CE, CMDCAS, ETL, UL, ISO-13485 and other standards and regulations for electronic medical devices.

ADM Tronics 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.

International Clients & Partners

ADM Tronics provides international clients and partners with an experienced and fully staffed, US-based FDA-Registered facility.

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.