TelaCode is a company dedicated to providing services for those who are looking to develop software for products or devices which will operate in a clinical environment and have to comply with FDA regulations.

If you are currently managing a research and development group, developing a new product which is targeted for clinical use, you will be facing the difficult task of setting up a quality system, which complies with FDA requirements, under which you will be doing your development work.

TelaCode provides a service which will minimize the work in setting up your quality system, by providing a quality system for you from which you can do your research and development work. TelaCode has a full set of quality system web service, which you can use directly from your desktop. These services include document control, record control, source code control, and customer feedback.

Combined with these web services, is TelaCode's research and development management system, which guides the research and development process, in a manner required by FDA regulations. From the planning stages where the product requirements are defined, to the final stages of product validation in the clinic and 510K submission, the TelaCode management process covers the full spectrum of research and development activities.

The general approach is for you to adopt TelaCode's management system and web services, which will then place you into a research and development framework which follows FDA guidance. You can then focus all your time and energy on your project, leaving the FDA regulation details to TelaCode's management system. The final outcome will be that when you finish developing your product, it will comply with FDA regulations and will be ready for market entry, without you having to deal with all the FDA regulation headaches.

For further information, please contact TelaCode.