We can execute a regulatory project, any where in the world

We have submitted medical device submissions from sponsors all over the world through 22 time zones, in multiple languages under multiple regulatory systems. We are ready to meet your global challenge.


You may call us FDA regulatory affairs consultants - we prefer regulatory engineers. We shape the product. We are an active participant. A "regulatory affairs professional" is passive. They must wait until the design and documentation is complete and merely advises in very strict boundaries. We work from a blank piece of paper. They must have every thing filled out by others.


We work with the USA FDA (Food & Drug Administration) and the CDRH (Center for Devices & Radiological Health) and the Office of Device Evaluation (ODE) to do 510K (Pre Market Notifications), PMA (Pre-Market Approvals) and ANDA (Abbreviated New Drug Applications). GMP (Quality Systems) ISO-13485 and ISO/IEC/AAMI standards.


Our projects cover all medical devices: radiological imaging, computer controlled devices, lasers, software, electronics, injectable drugs, disposable blood tubing sets, sterile implants, teleconferencing, medical networking, disposables, catheters, In Vitro diagnostics and In Vivo diagnostics.


Let us submit a technical proposal for a new medical device 510(k). You will not receive better. No one gets medical devices to market faster than we do!