Welcome to Compliance Consultants...

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

What you do; what we do.

This specifies · what you do, and · what we do. This applies to most medical device development projects that require FDA "approval".

In our fixed fee costing, our responsibilities are open ended until you receive FDA "approval" whether that "approval" is one or three years. That is our fixed fee obligation. Our open ended responsibilities are those to create the application using your documents. We remain your advisor.

Initialization We start the project by discovering issues at the FDA that relate to your device. We associate these issues to We draft an agenda for a three-day trip. We visit you and visit with your people. We cover each inch of the device and the documentation. You must present the design, testing and documentation as a design review to us. We leave your facility and create a regulatory strategy and identify the engineering documentation required.

What you must do! You must generate the device, the data about the device and any data reflective of the design. You must research information about the design. This includes: · data about the material used, · choice of the design, and · selection of a substantial equivalent.

You have the responsibility to originate information. We will review documents and suggest revisions and directions. We are not responsible for creating the design. We are not responsible for creating documents. We do not conduct research on the technology. We often step over this line to be helpful…in the spirit of accelerating the completion of a project. We cannot accept the responsibility to accomplish a certain task unless we are commissioned in a specified statement of work with specified boundaries.

We take over! We look at the fundamental scientific percepts upon which your device works and derive tests necessary to substantiate that performance. We derive the various development stages necessary to test these scientific percepts. We look at the steps necessary to accomplish testing according to good design controls. We review your development test plan to understand what measurements you are taking at what stages of your proof of concept, prototype, pre-production and pilot production to establish a continuum in test data.

Don't have a test plan? You will. That is how we are better. We understand engineering voids in development systems and how to organize around them.

We establish the authentication of a calibrated dose or calibrated treatment level that is delivered to the patient. We advise how the calibrated dose or calibrated treatment should be documented, tested and maintained by calibration.

In the planning stage, we advise you of the documents that must be created to meet the FDA requirements. We review your assortment of engineering documentation to appraise the technical purpose, the content and the format. We review these documents for completeness. We develop a reference structure for the upward /downward relationship of documents.

We prepare the application. We revise the submission to incorporate any changes. We suggest work arounds in your development to expedite engineering product development and FDA "approval". We create a solution to minimize your FDA risks.

Based on your knowledge of the marketplace, you must identify companies who may have substantially equivalent products. If necessary, we will obtain competitive product brochures for use in the submission. We assist in compiling a competitive analysis to establish selling prices. We can research U.S. Medicare compensation levels to assist you in pricing your service/ product.

We investigate the operational modes to ensure the device is suited to its the clinical environment. We work with your subcontractors and suppliers to modify the design and documentation. We research standards (IEC, ISO, ANSI, AAMI, ANSI, etc.), guidance documents from the FDA's Center for Devices and Radiological Health, and specifications, etc.

We discover the requirements that your device must conform/comply with and create a compliance plan.

We work with you to answer any specific questions that arise from the various guidance documents. Usually, there are technical conflicts between the various standards and guidance documents. We have the necessary experience to resolve these dilemmas, which often frustrate medical device development.

We appraise your engineering design to understand if your engineering design fits within the requirements specified by the various agencies. We appraise your engineering documentation to understand if your engineering documentation fits within the requirements specified by the various agencies.

We research and present your manufacturing, quality assurance, procurement systems, documentation systems, safety reporting and warranty systems.

We research any new measurement or diagnostic phenomenon to understand the FDA's knowledge or comments as may apply.

We review all labeling, user manuals, instructions, user screens, software information, etc. to ensure it conforms to identifiable FDA guidelines.

We identify each potential issue which may be cited by the FDA in review of your application and create a remedy prior to filing to ensure the issues is treated appropriately in the submission.

We review your failure analysis against requirements and potential FDA issues.

We research any issues that may impact your regulatory position that is not covered in any guidance documents to understand risks and organize a strategy or remedy.

Usually, we call the FDA to understand issues not in writing. We research the functional group at the FDA to understand any recent episodes, which may apply to your submission. We visit with the FDA in Washington, if necessary.

Most FDA 510(K)'s are filed with often - casual - attention to the above items. That is why you hear about nightmares with the FDA. Usually the nightmares are NOT because of the FDA. Usually the nightmares are due to poorly planned medical device development and unenlightened applications. As you see, there is nothing unenlightened about what we do. When the above efforts are NOT accomplished: your application is at the risk. You must satisfy the FDA. You must supply more information in undefined areas. The danger is - once issues are raised -the effort to dispel an issue is greater than the effort to initially avoid the issue by including a threshold of information that satisfies the FDA. Our submissions are calculated to avoid the possibility of "predicable" questions.

Our contribution is we attend to these items in advance to reduce your risk and speed the potential of your approval.

When the FDA responds to your application, and asks questions, we have a rigorous technique to limit the questions to avoid a second round of questions.

We initially answer each technical question and draft the boundaries of the question to protect you from being led into a dangerous answer. We work with you to perfect each answer to satisfy the FDA and obtain "approval".

We create a volume to contain the answers and submit the answers to the FDA. Should a time extensions be required, we achieve the necessary delay for you. We are more "hands on" because we understand the engineering and regulatory aspects of the project. We perform every task necessary to achieve a speedy "approval" for you.

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