Scope

510Ks, PMAs and IDEs submitted to the FDA must have documentation that demonstrates you meet the requirements of Design Controls AND Good Manufacturing Practices. These two controls systems added together are now referred to as Quality Systems. At Compliance Consultants we are qualified and skilled to create documents, which you may need to supplement your submission.

Most new medical product innovators are so focused on the invention they often set aside the creation of documentation. Another reason for delay is that the creators see not what data is defined but what data is subject to change. It is the propensity for revision that delays the creation of documentation. Our process overcomes these delays and produces documents early in the development that are useful and endure for the transistion into production.

We create authentic, useful, complete engineering documentation with both content and format that will withstand the scrutiny of the USA FDA and / or ISO-9000.

The process we follow to create your documentation will fit your facility, personnel device, schedule and budget. Upon completion, these documents serve as valuable tools not only to control quality and product repeatability, but also to lower your unit cost. Our documents not only meet Good Manufacturing Practices, but also serve as a launching point for a complete ISO 9001 system.

We create a modularize system to divide function, task, training, knowledge, etc. We design documents to have a very narrow focus.

The narrow focus allows that a small group of documents “fit together” to support an activity such as Development Testing or Incoming Inspection. Your people can pick it up and immediately determine what it applies to and how to use it or change it.

Documents that we create are easy to read, easy to revise, highlight critical areas, and are worded plainly to eliminate ambiguities.

The documentation we create for you will:

• establish your product was developed according to standards;

·         verify your product is repeatable batch to batch;

• provide a mechanism to define & record changes to your procedures;      
• ensure users can operate your product correctly, 

·         maintain records to ensure your products can be traced to users.

We have “off-the shelf” documents similar to what you need in function, content and format.

We will present samples of many documents that cover various engineering & manufacturing controls, such as:

• Quality Assurance Standards,
• Requirements Specifications,
• Software Definition & Controls,
• Production Specifications,
• Validation Test Procedures,
• Test Data Records (to store results), 
• User Product Support Manuals,

·         Product Recall & Complaint Handling,

• Instruction Manuals and,

·         many examples of actual FDA submissions.

The FDA views documentation as labeling and considers that labeling is integral to the performance of the product: where if either the product or label is defective -- the same effect occurs to the user.

Since we are technically qualified, we create all documentation  on a turn-key basis. We interview, watch, and design documentation to serve your processes. Our documentation supports and enhances the product.  We quote each document as a separate stand-alone cost.

We create crystal clear, high performance specifications which are profusely illustrated, clear, and concise. Our documentation follows a special quality formula for consistency:

• artwork, tables and procedures that are easy to follow;
• an economy of  white space {all space is filled and all pages are used};
• consistency and presentation of  formal, styled, polished documents;
• consistency and purpose in common names, titles, and procedures;
• document /revision numbers that ensure easy identification and instant location.

We do not write Shakespeare. If the information cannot be in a drawing or block diagram, we put the data in a table. If the data cannot be placed in a table then we write procedural steps and at last, paragraphs.

As part of this task, you benefit by creation of  a disciplined, rigorous, flexible part numbering system to ensure distinction, control and revision.

We deliver a final package consisting of both a computer & paper version of all documents. 

You get useful, simple, complete documents.

Consider this special benefit. With useful documents you can identify and reduce the cost for sub-contractors to manufacturer or fabricate your proprietary components. With good documentation purchasing activities become routine. Without good documentation purchasing activities becomes risky and fraught with reversals.

Our process is a low cost method to create a Quality System that meets FDA and accelerates your path to ISO 9000.

Good documentation is a better investment for the success of launching your new medical device than most other expenses. It is essential and required by FDA Design Controls. Good documentation endures as an investment in your product.