Welcome to Compliance Consultants...

...the more you learn...the more you will want us for FDA!

A painter paints fine art but an art critic can only criticize art after the picture is finished. A composer writes music but a music teacher can only marvel at it.

If you are creating a new medical device, Compliance Consultants can contribute to the creation of your invention to shape your device to fit through the FDA's review process.

Most regulatory affairs consultants usually move technical papers from you to the FDA. They avoid the daily rigors of engineering decision making. We immerse ourselves in the engineering design and contribute to influencing the design, testing and documentation to improve your FDA position. We can "shape" your design to "fit" through the FDA review cycle. We use the term "shape" accurately. We affect the form not necessarily the substance.

Most regulatory affairs consultants can only act as a "critic". They contribute after your product is formed and tell you what is wrong. Compliance Consultants works from the start and assists you in creating the invention so the product meets the scrutiny of the FDA.

This difference between Compliance Consultants and regulatory affairs consultants is so different that we are the only ones who identify this difference. Refer to "How we are different". Most regulatory affairs consultants do not even understand the limitation of their contribution because they are inspectors from the production, auditing (ISO), writing or quality assurance (QC) world. They pride themselves in finding mistakes. We are engineers from the development world. We help you to not make those mistakes that QC engineers look for.

We elevate this issue because this has a significant impact on your overall schedule and the engineering design/re-work. Projects that we are part of, run smoother, take less time, and have fewer reversals. That means money to you. Your FDA "approval" becomes less risky.

Is your device a screening device used to refer a patient for additional testing or does your device operate within calibration factors that qualify your design as a diagnosis device? Which will it be: screening or diagnostic? What FDA guidance documents would supply information for design decision-making. Who do you listen to if there are no FDA guidance documents or if there are conflicts in the FDA guidance documents (which is the case for most NEW devices)?

Most "regulatory affairs professionals" are not trained in design. They are trained in support functions, such as QC, auditing ISO, OR even former FDA reviewers. We can design medical devices as well as interpret FDA issues. We talk circuit design, software function software design, software documentation, material selection, biocompatibility selection, test design, user application, design safety issues, plan sterilization process, interpret technical standards, etc. These are duties that most "regulatory affairs professionals" run from!

We were retained to replace one "regulatory affairs professional" group when they could not even identify what standards (FDA, ANSI, ISO, IEC, UL, CSA, AAMI etc.) that the design should meet. If seems that these consultants looked really good until they were asked to deal with technical problems, then they simply were unable to contribute to shaping the real development.

We shape the design, draft a preliminary plan for the regulatory strategy and assist in maturing the design from the earliest interval. Our contribution adds certainty into your development process.

With any mystery even slight amounts of direction can guide your development to avoid regulatory dilemmas. Compliance Consultants is able to supply technical advice to reduce risk and add certainty to the directions a development effort should follow.

copyright by Compliance Consultants, Stamford, CT USA, September 2001